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Dexcom, Inc, has issued a recall for G7 Apps and ONE+ Apps because of a software design error failing to alert users of unexpected sensor failures.
This recall involves correcting the devices via a software update and does not require removal of the product. The FDA has identified this recall as its most serious type, meaning it may cause serious injury or death without correction.
The affected products are
- Dexcom G7 Continuous Glucose Monitoring (CGM) Android App
- Dexcom G7 CGM iOS App
- Dexcom G7 CGM watchOS App
- Dexcom ONE+ CGM Android App
- Dexcom ONE+ CGM iOS App
The affected App versions include the Dexcom G7 Android, iOS, watchOS Apps with versions 2.8.0 or earlier and the Dexcom ONE+ CGM Android and iOS Apps with versions 1.4.0 or earlier.
What to Do
Dexcom sent all affected customers an Urgent Medical Device Correction Notification with the following instructions:
Users of Dexcom G7 iOS / G7 Watch iOS / Android App versions 2.8.0 and earlier must go to the App store and upgrade to the latest Dexcom G7 App version.
Users of Dexcom ONE+ iOS / Android App versions 1.4.0 and earlier need to upgrade to the latest ONE+ App version.
Previous versions contain a software design error that leads to a missed “Sensor Failed” alert when the sensor’s transmitter encounters a hardware/firmware failure. The affected App ends the CGM sensor session, stops reporting glucose values, and displays the “Start Sensor” screen or “No active sensor” message without alerting the user. This can result in the user missing glucose data, notifications, alerts, and alarms for an extended period, possibly resulting in a delay in treating hypoglycemia or hyperglycemia.
There have been no reported injuries or deaths related to this issue.
Contact Information
Patients in the US with questions about this recall should contact Dexcom Technical Support at 1-844-478-1600. Outside the US, patients can find local Technical Support contact information at Dexcom.com.
Kathleen Dallessio is the Senior Editor for Diabetes & Endocrinology and Nephrology at Medscape.
