Dexcom G4 PLATINUM (Pediatric) Safety Information

Dexcom G4 PLATINUM Safety Information

Dexcom SEVEN PLUS Safety Information

Dexcom STUDIO Safety Information



Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring

INDICATIONS FOR USE

The Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons ages 2 to 17 years with diabetes. The system is intended for single patient use and requires a prescription.

The Dexcom G4 PLATINUM (Pediatric) System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.

The Dexcom G4 PLATINUM (Pediatric) System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the Dexcom G4 PLATINUM (Pediatric) System results should be based on the trends and patterns seen with several sequential readings over time.

IMPORTANT USER INFORMATION

Please review your product instructions before using your continuous glucose monitoring system. Indications, contraindications, warnings, precautions, cautions, and other important user information can be found in your product instructions. Discuss with your healthcare professional how you should use your sensor trend information to help manage your diabetes. Your product instructions contain important information on troubleshooting your system and on the performance characteristics of the device.

CONTRAINDICATIONS

  • Remove the Dexcom G4 PLATINUM sensor, transmitter, and receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. The Dexcom G4 PLATINUM (Pediatric) System has not been tested during MRI or CT scans or with diathermy treatment. The magnetic fields and heat could damage the device so that it might not display sensor glucose readings or provide alerts, and you might miss a low or high blood glucose value.
  • Taking medications with acetaminophen (such as Tylenol®) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person.

WARNINGS

  • Do not use the Dexcom G4 PLATINUM (Pediatric) CGM System until you have thoroughly reviewed the training materials. Incorrect use might lead you to misunderstand the CGM information or affect system accuracy. This could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
  • Do not use the Dexcom G4 PLATINUM (Pediatric) System for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM (Pediatric) System does not replace a blood glucose meter. Always use the values from your blood glucose meter for treatment decisions. Blood glucose values may differ from sensor glucose readings. Solely relying on the sensor glucose alerts and readings for treatment decisions could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
  • Do not ignore symptoms of high and low glucose. If your sensor glucose alerts and readings do not match your symptoms, measure your blood glucose with a blood glucose meter even if your sensor is not reading in the high or low range. Solely relying on the sensor glucose alerts and readings for treatment decisions could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
  • In a pediatric clinical study, larger differences were observed between this CGM device and actual blood glucose values compared to those differences observed in the adult clinical study. Use your blood glucose meter for treatment decision.
  • In a pediatric clinical study, a significant number of low glucose events were not detected by CGM. Do not rely solely on CGM alerts to detect low glucose.
  • Do calibrate at least once every 12 hours. Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate and glucose alerts to become unreliable. This could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
  • Do not ignore sensor fractures. Sensors may fracture on rare occasions. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken sensor, please report this to our Technical Support department at 1.877.339.2664 or 1.858.200.0200.
  • Do not use the Dexcom G4 PLATINUM (Pediatric) System in pregnant women or persons on dialysis. The system is not approved for use in pregnant women or persons on dialysis and has not been evaluated in these populations. Sensor glucose readings may be inaccurate in these populations and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
  • Do not use the Dexcom G4 PLATINUM (Pediatric) System in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect the performance of the system. Sensor glucose readings may be inaccurate in critically ill patients, and solely relying on the sensor glucose alerts and readings for treatment decisions could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
  • Do not insert the sensor in sites other than the belly (abdomen) or upper buttocks. Other sites have not been studied and are not approved. Use in other sites might cause sensor glucose readings to be inaccurate and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
  • Do not expect alerts from the Dexcom G4 PLATINUM (Pediatric) System until after the 2-hour startup. You will NOT get any sensor glucose readings or alerts until after the 2-hour startup ends AND you complete the startup calibration. During this time you might miss severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
  • Do not use your transmitter or receiver if it is damaged/cracked. This could create an electrical safety hazard or malfunction, which might cause electrical shocks.
  • Store the sensor at temperatures between 36° F - 77° F for the length of the sensor’s shelf life. You may store the sensor in the refrigerator if it is within this temperature range. The sensor should not be stored in a freezer. Storing the sensor improperly might cause the sensor glucose readings to be inaccurate, and you might miss severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
  • Do not allow young children to hold the sensor, transmitter or transmitter kit box without adult supervision. The sensor and transmitter include small parts that may pose a choking hazard. Keep the transmitter kit box away from young children; it contains a magnet that should not be swallowed.

PRECAUTIONS

  • Do not open the sensor package until you have washed your hands with soap and water, and let them dry. You may contaminate the insertion site and suffer an infection if you have dirty hands while inserting the sensor.
  • Do not insert the sensor until you have cleaned the skin with a topical antimicrobial solution, such as isopropyl alcohol, and allowed the skin to dry. Inserting into unclean skin might lead to infection. Do not insert the sensor until the cleaned area is dry so the sensor adhesive will stick better.
  • Avoid using the same spot repeatedly for sensor insertion. Rotate your sensor placement sites, and do not use the same site for two sensor sessions in a row. Using the same site might cause scarring or skin irritation.
  • Avoid inserting the sensor in areas that are likely to be bumped, pushed or compressed or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose. Insertion in those areas might affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
  • Avoid injecting insulin or placing an insulin pump infusion set within 3 inches of the sensor. The insulin might affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
  • Do not use the sensor if its sterile package has been damaged or opened. Using an unsterile sensor might cause infection.
  • To calibrate the system, do enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose measurement. Do not enter sensor glucose readings for calibration. Entering incorrect blood glucose values, blood glucose values obtained more than 5 minutes before entry, or sensor glucose readings might affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
  • Do not calibrate if your blood glucose is changing at a significant rate, typically more than 2 mg/dL per minute. Do not calibrate when your receiver screen is showing the rising or falling single arrow or double arrow, which indicates that your blood glucose is rapidly rising or falling. Calibrating during significant rise or fall of blood glucose may affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
  • The system accuracy may be affected when your glucose is changing at a significant rate (e.g., 2-3 mg/dL/min or more than 3 mg/dL each minute), such as during exercise or after a meal.
  • Avoid separating the transmitter and receiver by more than 20 feet. The transmission range from the transmitter to the receiver is up to 20 feet without obstruction. Wireless communication does not work well through water so the range is much less if you are in a pool, bathtub, or on a water bed, etc. Types of obstruction differ and have not been tested. If your transmitter and receiver are farther than 20 feet apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter and result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
  • Keep the USB port cover on the receiver closed whenever the USB cable is not attached. If water gets into the USB port, the receiver could become damaged and stop displaying readings or providing alerts and result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
  • Do not use alternative blood glucose site testing (blood from your palm or forearm, etc.) for calibration. Alternative site blood glucose values may be different than those taken from a fingerstick blood glucose value and may not represent the timeliest blood glucose value. Use a blood glucose value taken only from a fingerstick for calibration. Alternative site blood glucose values might affect sensor accuracy and result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
  • Do not discard your transmitter. It is reusable. The same transmitter is used for each session until you have reached the end of the transmitter battery life.
  • The Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver are not compatible with the SEVEN/SEVEN PLUS Transmitter and Receiver. Different generations will not connect with each other and will not work. Also make sure to use the correct version of Dexcom STUDIO with your system.
  • CAUTION

    U.S. (Federal) law restricts the sale of the Dexcom G4 PLATINUM (Pediatric) System to sale by or on order of a physician.




    Dexcom G4 PLATINUM Continuous Glucose Monitoring

    INDICATIONS FOR USE

    The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The system is intended for single patient use and requires a prescription.

    The Dexcom G4 PLATINUM System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.

    The Dexcom G4 PLATINUM System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the Dexcom G4 PLATINUM System results should be based on the trends and patterns seen with several sequential readings over time.

    IMPORTANT USER INFORMATION

    Please review your product instructions before using your continuous glucose monitoring system. Contraindications, warnings, precautions, cautions, and other important user information can be found in your product instructions. Discuss with your healthcare professional how you should use your sensor trend information to help manage your diabetes. Your product instructions contain important information on troubleshooting your system and on the performance characteristics of the device.

    CONTRAINDICATIONS

    • Remove the Dexcom G4 PLATINUM sensor, transmitter, and receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. The Dexcom G4 PLATINUM System has not been tested during MRI or CT scans or with diathermy treatment. The magnetic fields and heat could damage the device so that it might not display sensor glucose readings or provide alerts, and you might miss a low or high blood glucose value.
    • Taking medications with acetaminophen (such as Tylenol) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person.

    WARNINGS

    • Thoroughly review the training materials included with your CGM system before using the Dexcom G4 PLATINUM CGM System. Incorrect use might lead to you misunderstanding the information provided by your system, or might affect system performance, and you might miss a low or high blood glucose value.
    • Do not use the Dexcom G4 PLATINUM System for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM System does not replace a blood glucose meter. Always use the values from your blood glucose meter for treatment decisions. Blood glucose values may differ from sensor glucose readings. Using the sensor glucose readings for treatment decisions could lead to low or high blood glucose value.
    • Do not ignore symptoms of high and low glucose. If your sensor glucose readings do not match your symptoms, measure your blood glucose with a blood glucose meter even if your sensor is not reading in the high or low range, so you do not miss a low or high blood glucose value.
    • Calibrate at least once every 12 hours. Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value.
    • Sensors may fracture on rare occasions. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken sensor, please report this to our Technical Support department at 1.877.339.2664 or 1.858.200.0200.
    • The Dexcom G4 PLATINUM System is not approved for use in children or adolescents, pregnant women or persons on dialysis.
    • It is not known how different conditions or medications common to the critically ill population may affect the performance of the system. Therefore, the use of this system in the critically ill population is not recommended.
    • Sensor placement and insertion is not approved for sites other than the belly (abdomen).
    • If your transmitter or receiver case is damaged/cracked, do not use it. This could create an electrical safety hazard or malfunction, which might cause electrical shocks.
    • Store the sensor at temperatures between 36° F - 77° F for the length of the sensor’s shelf life. You may store the sensor in the refrigerator if it is within this temperature range. The sensor should not be stored in a freezer. Storing the sensor improperly might cause the sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value.

    PRECAUTIONS

    • Before opening the sensor package, wash your hands with soap and water, and let them dry. You may contaminate the insertion site and suffer an infection if you have dirty hands while inserting the sensor.
    • Before inserting the sensor, clean the skin with a topical antimicrobial solution, such as isopropyl alcohol, and allow to dry. This may help prevent infection. Do not insert the sensor until the cleaned area is dry so the sensor adhesive will stick better.
    • Change the site where you place the sensor with each insertion. Using the same site too often might not allow the skin to heal, and might cause scarring or skin irritation.
    • Avoid inserting the sensor in areas that are likely to be bumped, pushed or compressed or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose. Insertion in those areas might affect sensor performance, and you might miss a low or high blood glucose value.
    • Avoid injecting insulin or placing an insulin pump infusion set within 3 inches of the sensor. The insulin might affect sensor performance, and you might miss a low or high blood glucose value.
    • Do not use the sensor if its sterile package has been damaged or opened. Using an unsterile sensor might cause infection.
    • To calibrate the system, enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose measurement. Entering incorrect blood glucose values or blood glucose values from more than 5 minutes before entry might affect sensor performance, and you might miss a low or high blood glucose value.
    • Do not calibrate if your blood glucose is changing at a significant rate, typically more than 2 mg/dL per minute. Do not calibrate when your receiver screen is showing the rising single arrow or double arrow, which indicates that your blood glucose is rising 2-3 mg/dL/min or more than 3 mg/dL/min. Also, do not calibrate when your receiver screen is showing the falling single arrow or double arrow, which indicates that your blood glucose is falling 2-3 mg/dL/min or more than 3 mg/dL/min. Calibrating during significant rise or fall of blood glucose may affect accuracy of sensor glucose readings.
    • The system accuracy may be affected when your glucose is changing at a significant rate (e.g., 2-3 mg/dL/min or more than 3 mg/dL each minute), such as during exercise or after a meal.
    • The transmission range from the transmitter to the receiver is up to 20 feet without obstruction. Wireless communication does not work well through water so the range is much less if you are in a pool, bathtub, or on a water bed, etc. Types of obstruction differ and have not been tested. If your transmitter and receiver are farther than 20 feet apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter and you might miss a low or high blood glucose value.
    • Keep the USB port cover on the receiver closed whenever the USB cable is not attached. If water gets into the USB port, the receiver could become damaged and stop displaying readings or providing alerts, and you might miss a low or high blood glucose value.
    • Do not use alternative blood glucose site testing (blood from your palm or forearm, etc.) for calibration. Alternative site blood glucose values may be different than those taken from a fingerstick blood glucose value and may not represent the timeliest blood glucose value. Use a blood glucose value taken only from a fingerstick for calibration. Alternative site blood glucose values might affect sensor performance, and you might miss a low or high blood glucose value.
    • Do not discard your transmitter. It is reusable. The same transmitter is used for each session until you have reached the end of the transmitter battery life.
    • The Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver are not compatible with the SEVEN/SEVEN PLUS Transmitter and Receiver. Different generations will not connect with each other and will not work. Also make sure to use the correct version of Dexcom Studio with your system.
    • CAUTION

      U.S. (Federal) law restricts the sale of the Dexcom G4 PLATINUM System to sale by or on order of a physician.




      SEVEN PLUS Continuous Glucose Monitoring

      Indication for use

      The SEVEN PLUS Continuous Glucose Monitoring System is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The SEVEN PLUS System is intended for use by patients at home and in health care facilities. The device is for prescription use only.

      The SEVEN PLUS Continuous Glucose Monitoring System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.

      The SEVEN PLUS Continuous Glucose Monitoring System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the SEVEN PLUS System results should be based on the trends and patterns seen with several sequential readings over time.

      Contraindications

      The SEVEN PLUS System must be removed prior to Magnetic Resonance Imaging (MRI).

      Use of acetaminophen-containing medications while the SEVEN Sensor is inserted may affect the performance of the device.

      Warnings

      This device is not designed to replace a blood glucose meter. The SEVEN PLUS must be used with a blood glucose meter.

      Treatment decisions should not be based solely on results from the SEVEN PLUS. You must confirm with a blood glucose meter before making therapeutic adjustments.

      Symptoms related to low or high blood glucose levels should not be ignored. If you have symptoms of low or high glucose, use your blood glucose meter to check the SEVEN PLUS results.

      You should update the SEVEN PLUS’ calibration every 12 hours at a minimum. The performance of the SEVEN PLUS System when calibrated less frequently than every 12 hours has not been studied.

      Sensors fracture on rare occasions. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken sensor, please report this to our Technical Support department.

      The SEVEN and SEVEN PLUS Systems are not approved for use in children or adolescents, pregnant women or persons on dialysis.

      The safety and effectiveness of the SEVEN and SEVEN PLUS Systems have not been evaluated for sensor probe insertion sites other than the skin of the abdomen.

      Precautions

      Always wash hands with soap and water before opening the Sensor package. After opening the package, avoid touching the adhesive area.

      Before inserting the Sensor, always clean the skin at the Sensor insertion location with a topical antimicrobial solution such as isopropyl alcohol. Do not apply the Sensor until the cleaned area is dry.

      Establish a rotation schedule for choosing each new Sensor location. Avoid Sensor locations that are constrained by clothing, accessories, or subjected to rigorous movement during exercise.

      Avoid injecting insulin or placing an insulin pump infusion set within 3 inches of a Sensor.

      The Sensor is sterile in its unopened, undamaged package. Do not use any Sensor if its sterile package has been previously damaged or opened.

      For OpenChoice Calibration you must enter the exact fingerstick reading that your blood glucose meter displays. Enter all fingerstick readings for calibration within 5 minutes. Entering incorrect fingerstick readings that occurred more than 5 minutes ago will affect device performance.

      Please note, the performance characteristics section of the SEVEN PLUS User’s Guide has changed to reflect the recent study done. The overall results of the trial showed that SEVEN PLUS System will provide you more continuous glucose readings, and you should expect more of your Sensors to provide data for the entire 7-day use period. Note that the data described in the Performance Section also showed a difference from the SEVEN PLUS to the original SEVEN device in performance in the low glucose region (40-80 mg/dL). Our study showed that at 50 mg/dL blood glucose, the device reported glucose to be as high as 64 mg/dL and at 80 mg/dL blood glucose; the device reported glucose to be as high as 90 mg/dL. Because the performance of the SEVEN PLUS System varies from the original, it is important that you assess how the new generation device performs for you, especially in the low range. You should review the performance of this device with your healthcare provider to understand how well the SEVEN PLUS System performs.



      Dexcom STUDIO Continuous Glucose Monitoring Software

      Indications for use

      The Dexcom Studio Data Manager software is an accessory software program intended to allow the transfer of glucose data stored by the Dexcom Continuous Glucose Monitoring System into a personal computer (PC). The software can be used by either a clinician or an end user.

      WARNING: This software does not provide any medical advice and may not be relied upon for that purpose. Do not make fundamental changes in your treatment program without talking to your healthcare professionals.