Date: June 03, 2025
Urgent: Medical Device Correction UPDATE Dexcom G6 Receiver – MT27408-1, Dexcom G7 Receiver – MT26403-0
On May 12, 2025, Dexcom issued an Urgent Medical Device Correction notification concerning Dexcom receivers not providing audio output to alerts/alarms as expected. We are providing this updated notification to provide you with additional important safety information, and to help you identify if your Dexcom receiver may be impacted by this issue.
Details on Affected Devices:
This Urgent Medical Device Correction Update applies ONLY to users of Dexcom Receivers with a part number listed in Table 1 below. Users of a receiver with a part number listed in Table 1 should follow the Recommended Customer Actions to check the receiver serial number to find out if their receiver is affected by this issue. See Image 4 at the bottom of this notice for detail on where you can find the part number and serial number for your Receiver:
This Urgent Medical Device Correction Update applies ONLY to users of Dexcom Receivers with a part number listed in Table 1 below. Users of a receiver with a part number listed in Table 1 should follow the Recommended Customer Actions to check the receiver serial number to find out if their receiver is affected by this issue. See Image 4 at the bottom of this notice for detail on where you can find the part number and serial number for your Receiver:
Table 1: Impacted Receiver Information - US
Part Number | SKUs | Part Description |
MT27408-1 | STK-FM-001, STK-FR-001 | Dexcom G6 Receiver |
MT26403-0 | STK-AT-011, STK-AT-012, STK-AT-013 | Dexcom G7 Receiver |
Description of the Problem:
To date, users of the Dexcom G6 or G7 Receiver have reported an issue in which the receiver may not provide audio output to alerts/alarms as expected.
To date, users of the Dexcom G6 or G7 Receiver have reported an issue in which the receiver may not provide audio output to alerts/alarms as expected.
Note: An impacted receiver will still provide an alert through vibration and visual prompts. Other receiver and system functions, including accuracy, are not impacted.
Risk to Health:
If a user experiences a lack of receiver audio due to this issue, it may result in delayed and/or missed detection of severe hypoglycemia or hyperglycemia. Although a speaker test could identify a defective receiver, the malfunction can occur at any time without warning, even if the receiver has recently passed the speaker test. As of May 2025, 112 complaints have been received globally with confirmed association to this speaker malfunction. Globally, there have been 56 reports of severe adverse events (including seizure, loss of consciousness, vomiting, or unspecified hypoglycemic/hyperglycemic symptoms; all users recovered) potentially associated with this issue.
If a user experiences a lack of receiver audio due to this issue, it may result in delayed and/or missed detection of severe hypoglycemia or hyperglycemia. Although a speaker test could identify a defective receiver, the malfunction can occur at any time without warning, even if the receiver has recently passed the speaker test. As of May 2025, 112 complaints have been received globally with confirmed association to this speaker malfunction. Globally, there have been 56 reports of severe adverse events (including seizure, loss of consciousness, vomiting, or unspecified hypoglycemic/hyperglycemic symptoms; all users recovered) potentially associated with this issue.
Recommended Customer Actions:
- Verify if your receiver is affected by this issue:Check the serial number for any receiver(s) you use, with a part number listed in Table 1, by visiting this webpage: https://dexcom.com/en-us/checkreceiver
- If you need assistance with the serial number verification process, please contact Dexcom Technical Support at 1-844-478-1600.
- If your receiver is affected, contact Dexcom Technical Support at 1-844-478-1600 to coordinate return of the affected receiver and a no charge replacement.
- Whether or not your receiver is affected by this notification, Dexcom continues to recommend regular testing of the speaker. Test speaker function every time you charge your receiver. When you charge, a reminder prompt will invite you to test speaker function. See Reference Images 1-3 below.
- Electively test the receiver speaker at any point through the menu: Menu>Information>Receiver>Speaker>Test
- If a speaker test is not successful, contact Dexcom Technical Support at 1-844-478-1600. If a speaker test is successful, continue to test speaker function regularly.
Contact reference information:
If you need assistance related to this issue or notification, please call Dexcom Technical Support at 1- 844-478-1600. Technical Support is available 24 hours a day/7 days a week to assist you.
If you need assistance related to this issue or notification, please call Dexcom Technical Support at 1- 844-478-1600. Technical Support is available 24 hours a day/7 days a week to assist you.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Reference Images:
Image 4: Examples of Affected Receiver
Note: The part number and serial number are both listed on the back of the receiver as shown in the image to the right/below):
