Urgent: Medical Device Correction UPDATE

Attention: Valued Dexcom Customer,

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 the following Dexcom Receivers

• Dexcom G6 Receiver with a part number of MT27408-1 with the SKU of STK-FM-001 or STK-FR-001
• Dexcom G7 Receiver with a part number MT26403-0 with the SKU of STK-AT-011, STK-AT-012, or STK-AT-013.

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

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

Recommended Customer Actions: 

• Verify if your receiver is affected by this issue: Check the serial number for any receiver(s) you use 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.
  • 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. 

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: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm 

Regular Mail or Fax: Download form https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting 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

You can download a copy of this notice that also includes images of the devices here: https://www.va.gov/files/2025-06/Urgent-Medical-Device-Correction-Notification_US.pdf