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Dexcom G5 Mobile Continuous Glucose Monitoring System

Safety Information

Indications for Use

The Dexcom G5 Mobile Continuous Glucose Monitoring System is a glucose monitoring system indicated for the management of diabetes in persons age 2 years and older. The Dexcom G5 Mobile CGM System is designed to replace fingerstick blood glucose testing for diabetes treatment decisions.

Interpretation of the Dexcom G5 Mobile CGM System results should be based on the glucose trends and several sequential readings over time. The Dexcom G5 Mobile CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. 

The Dexcom G5 Mobile CGM System is intended for use by patients at home and in healthcare facilities.

Important User Information

Failure to use the Dexcom G5 Mobile CGM System and its components according to the instructions for use and all indications, contraindications, warnings, precautions, and cautions may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from your Dexcom G5 Mobile CGM System do not match your symptoms or expectations, use a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions. Seek medical attention when appropriate.

Please review the product instructions before using the Dexcom G5 Mobile CGM System. Indications, contraindications, warnings, precautions, cautions, and other important user information can be found in the product instructions that are included with, or accompany, the Dexcom G5 Mobile CGM System. Discuss with your healthcare professional how you should use the information displayed on the Dexcom G5 Mobile CGM System to help manage your diabetes. The product instructions contain important information on troubleshooting the Dexcom G5 Mobile CGM System and on the performance characteristics of the system.

Contraindications

MRI/CT/ Diathermy

Remove the Dexcom G5 Mobile CGM System sensor, transmitter, and receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment.

The Dexcom G5 Mobile CGM System has not been tested during MRI or CT scans or with diathermy treatment. The magnetic fields and heat could damage the components of the Dexcom G5 Mobile CGM System, which may cause it to display inaccurate blood glucose readings or may prevent alerts.

Medications

Taking medications with paracetamol/acetaminophen while wearing the Dexcom G5 Mobile CGM System may inaccurately raise the glucose readings generated by the Dexcom G5 Mobile System User Guide Indications for Use and Safety Statement 12 Dexcom G5 Mobile CGM System. The level of inaccuracy depends on the amount of paracetamol/acetaminophen active in your body and is different for each person. Do not rely on continuous glucose monitoring (CGM) data produced by the Dexcom G5 Mobile CGM System if you have recently taken paracetamol/acetaminophen.

Warnings

Sensor Fractures

Do not ignore sensor fractures. Sensors may fracture or detach from the sensor pod 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 your local Dexcom representative.

Do Not Use Damaged Goods

If the Dexcom G5 Mobile CGM System Receiver or G5 Mobile Transmitter is damaged or cracked, do not use it. This could create an electrical safety hazard causing possible electrical shocks resulting in injury. In addition, a damaged or cracked G5 Mobile Receiver or G5 Mobile Transmitter may cause the Dexcom G5 Mobile CGM System not to function properly.

Choking

Do not allow young children to hold the sensor or transmitter without adult supervision. The sensor and transmitter include small parts that may pose a choking hazard.

The following may result in:

•missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)

•making a treatment decision that results in injury

Review Training Materials

Thoroughly review the training materials included with your Dexcom G5 Mobile CGM System before use. Incorrect use of the Dexcom G5 Mobile CGM System could lead you to misunderstand information produced by the system or might affect the system’s performance.

Diabetes Treatment Decisions

If your Dexcom G5 Mobile CGM System does not display a sensor glucose reading or if you are getting inconsistent readings, use a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions.

The following may result in:

• missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)

• making a treatment decision that results in injury

Diabetes Treatment Decisions

If your Dexcom G5 Mobile CGM System does not display a sensor glucose reading or if you are getting inconsistent readings, use a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions.

Do Not Ignore Low/High Symptoms

Do not ignore symptoms of low or high glucose. If your glucose alerts and readings do not match your symptoms or expectations, you should obtain a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions or seek immediate medical attention.

Who Should Not Use

The Dexcom G5 Mobile CGM System was not evaluated or approved for the following persons:

  • Pregnant women
  • Persons on dialysis

The Dexcom G5 Mobile CGM System’s accuracy has not been tested in people within these groups and the system’s glucose readings may be inaccurate.

Calibrate on Schedule

Calibrate the Dexcom G5 Mobile CGM System at least once every 12 hours. The Dexcom G5 Mobile CGM System needs to be calibrated in order to provide accurate readings. Do not use the Dexcom G5 Mobile CGM System for diabetes treatment decisions unless you have followed the prompts from the device and calibrated every 12 hours after the initial calibration.

Placement

Do not insert the sensor component of the Dexcom G5 Mobile CGM System in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years). The placement and insertion of the sensor component of the Dexcom G5 Mobile CGM System is not approved for other sites. If placed in other areas, the Dexcom G5 Mobile CGM System may not function properly.

The following may result in:

• missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)

• making a treatment decision that results in injury

Initial Calibration: Data/Alarm/Alert

Do not expect sensor glucose readings or alarms/alerts from the Dexcom G5 Mobile CGM System until after the 2-hour startup. The Dexcom G5 Mobile CGM System will NOT provide any sensor glucose readings or alarms/alerts until after the 2-hour startup ends AND you complete the startup calibration. Use fingerstick glucose values from your blood glucose meter during the 2-hour startup.

Sensor Storage

Store the sensor at temperatures between 2° C-25° C 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 the freezer.

Storing the sensor improperly might cause the sensor glucose readings to be inaccurate

Smart Device Settings

Your smart device’s internal settings override any Dexcom G5 Mobile App setting
To receive Alarm or Alerts you must:

  • Make sure the notifications for the G5 Mobile App are turned on in the setting’s menu of your smart device
  • Check that the G5 Mobile App hasn’t been shut down by your smart device
  • In order for the G5 Mobile App to function properly, you must turn on Bluetooth® on your smart device
  • The Do Not Disturb feature on your smart device (if available) must be turned off
  • Restart the G5 Mobile App after your smart device is restarted
  • Set the volume on your smart device at a level you can hear
  • Do not close the G5 Mobile App; always run the app in the background

If the settings on your smart device are incorrect your Dexcom G5 Mobile CGM System may not function properly.

The Dexcom G5 Mobile CGM System Alarm/Alert vibrations are not any different from other vibrating apps on your smart device. Medical device apps, like the Dexcom G5 Mobile CGM System App, do not have any special priorities over your smart device’s features. You cannot determine if a vibration is a notification from your Dexcom G5 Mobile CGM System App or another app. The only way to know is to look at the screen.

The following may result in:

  • missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)
  • making a treatment decision that results in injury

Missed an Alarm or Alert?

An Alarm or Alert from the Dexcom G5 Mobile CGM System App cannot be heard through your smart device’s speakers if headphones are plugged in.

Make sure you unplug your headphones when you are done using them, otherwise you might not hear an Alarm or Alert from the Dexcom G5 Mobile CGM System.

Precautions

Sensor Package

Do not use the G5 Mobile Sensor if its sterile package has been damaged or opened. Using a non-sterile sensor might cause infection.

Clean and Dry Before Using

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 near the insertion site 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.

Reusable: Do Not Throw Away

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’s battery life.

The following may result in:

• missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)

• making a treatment decision that results in injury

Be Accurate, Be Quick

To calibrate the system, enter the exact blood glucose value displayed on your blood glucose meter within five minutes of a carefully performed fingerstick glucose measurement.

Do not enter the Dexcom G5 Mobile CGM System’s 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 performance.

The following may result in:

missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)

•making a treatment decision that results in injury

Treatment Decisions

Make diabetes treatment decisions based on the combination of the sensor glucose reading, trend arrow, trend graph, and/or actionable alerts generated by the Dexcom G5 Mobile CGM System.

Expiration Date

Do not use Dexcom G5 Mobile CGM Sensors that are beyond their expiration date. Before inserting a sensor, confirm the expiration date listed on the package label in the following format: YYYY-MM-DD.

Do not use sensors that are beyond their expiration date because the sensor glucose readings might not be accurate.

Sensor Placement

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 these areas might affect sensor accuracy.

Avoid injecting insulin or placing an insulin pump infusion set within 7.5 cm of the sensor. The insulin might affect sensor performance.

Use Correct Transmitter, Receiver, and Sensor

Different generations of Dexcom continuous glucose monitoring system transmitters and receivers are not interchangeable with each other.

The Dexcom G5 Mobile CGM System’s transmitter and receiver are not compatible with the Dexcom G4® PLATINUM CGM System’s transmitter and receiver. The Dexcom G5 Mobile CGM System will not work if you mix transmitter and receiver components from different generations.

You can use either a Dexcom G4 PLATINUM Sensor or Dexcom G5 Mobile/G4 PLATINUM Sensor with your Dexcom G5 Mobile CGM System. 

The following may result in:

• missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)

• making a treatment decision that results in injury

Communication Range

Avoid separating the transmitter and receiver by more than 6 meters. The transmission range from the transmitter to the receiver is up to 6 meters 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 6 meters apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter.

Setting Alarm/Alert Notifications

When using both a receiver and a smart device with your Dexcom G5 Mobile CGM System, you must set your settings separately in each. If you set up one device and then use another, you might not get an Alarm or Alert.

Is It On?

If the receiver or smart device is turned off (Shut Down), it will not display sensor data, information, Alarm or Alerts generated by the Dexcom G5 Mobile CGM System. Make sure the Display Devices are turned on; otherwise you will not get sensor glucose readings or Alarm or Alerts.

Keep Receiver Dry

Keep the USB port cover on the receiver closed whenever the USB cable is not attached. Do not submerge the receiver in water.

If water gets into the USB port, the receiver could become damaged and stop displaying readings or providing alerts.

No Alternative Site Testing

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 the Dexcom G5 Mobile CGM System’s accuracy.

The following may result in:

• missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)

• making a treatment decision that results in injury

When Not To Calibrate

Do not calibrate if your blood glucose is changing at a significant rate, typically more than 0.11 mmol/L 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 rapid rise or fall of blood glucose may affect sensor accuracy.

 

Safety Information

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 2 and older) with diabetes. The system is intended for use by patients at home and in healthcare facilities.

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

  • The blood glucose value from your blood glucose meter should be used for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM System does not replace a blood glucose meter.
  • The Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver must be removed prior to Magnetic Resonance Imaging (MRI), CT scan, or diathermy treatment. The Dexcom G4 PLATINUM System has not been tested during MRI or CT scans or with diathermy treatment, and it is unknown if there are safety or performance issues.
  • Taking acetaminophen (paracetamol) containing products (such as Tylenol) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen (paracetamol) active in your body.

WARNINGS

  • Do not use the Dexcom G4 PLATINUM CGM System until after you have been trained or viewed the training materials included with your CGM system.
  • The blood glucose value from your blood glucose meter should be used for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM System does not replace a blood glucose meter. Blood glucose values may differ from sensor glucose readings. The direction, rate of glucose change, and trend graph on your Dexcom G4 PLATINUM System provide additional information to help with your diabetes management decisions.
  • Symptoms of high and low glucose should not be ignored. If your sensor glucose readings do not fit with your symptoms, you should measure your blood glucose with a blood glucose meter.
  • Your sensor glucose readings may be inaccurate if you calibrate less than every 12 hours.
  • 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 your local distributor
  • The Dexcom G4 PLATINUM System is not approved for use in pregnant women or persons on dialysis.
  • Sensor placement is not approved for sites other than under the skin of the belly (abdomen) or, in the case of patients between the ages of 2 and 17, the belly or upper buttocks.
  • If your transmitter or receiver case is damaged/cracked, do not use them, as this could create an electrical safety hazard or malfunction.
  • 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

  • Before opening the sensor package, wash your hands with soap and water and dry them to avoid contamination.
  • Before inserting the sensor, always clean the skin at the sensor insertion location with a topical antimicrobial solution, such as isopropyl alcohol. This may help prevent infection. Do not apply the sensor until the cleaned area is dry so that it will stick better.
  • Change the site where you place your sensor with each insertion to allow your skin to heal.
  • Avoid 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.
  • Avoid injecting insulin or placing an insulin pump infusion set within 7.62 cm of the sensor in case the insulin affects the sensor glucose readings.
  • The sensor is sterile in its unopened, undamaged package. Do not use any sensor if its sterile package has been previously damaged or opened.
  • To calibrate the system, you must 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 ago could result in inaccurate sensor glucose readings.
  • The transmission range from the transmitter to the receiver is up to 6 meters without obstruction. Wireless communication does not work well through water so the range is much less if you are in a pool, bathtub, water bed, etc.
  • Sensors should be stored at temperatures between 2° C - 25° C for the length of the shelf life. You may store your sensors in the refrigerator if it is within this temperature range. Sensors should not be stored in a freezer.
  • Keep the USB port cover on the receiver closed whenever the USB cable is not attached. The receiver may malfunction if water gets into the USB port.