Dexcom continuous glucose monitor apps fail to alert on transmitter failure
Dexcom G7 and ONE+ CGM apps fail to alert when the transmitter fails. The app silently stops glucose monitoring without notifying the user, risking missed detection of dangerous blood glucose events and delayed treatment.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Under the classification rules, Class I medical device recalls never score below 4. Though no illnesses have been reported, the potential for missed detection of life-threatening blood glucose levels justifies the Severe rating.
Plain-English summary
Dexcom G7 and Dexcom ONE+ continuous glucose monitoring system apps are affected. The app software versions involved are: G7 versions 2.8.0 or earlier (for iOS, watchOS, and Android), and ONE+ versions 1.4.0 or earlier (for iOS and Android).
When the transmitter experiences a hardware or firmware failure and sends a "transmitterFailed" error message, the app should display a "Sensor Failed" alert. However, the affected app versions instead silently end the CGM sensor session without alerting the user. The app stops reporting glucose values and displays only a "Start Sensor" screen or "No active sensor" message.
This failure to alert users creates a serious risk: users will not know their continuous glucose monitor has stopped working. As a result, users may miss detection of dangerously high blood glucose (hyperglycemia) or dangerously low blood glucose (hypoglycemia) events. The delay in detecting these dangerous conditions and receiving treatment could result in serious health consequences.
This is a Class I FDA recall. Approximately 41,629 devices have been distributed worldwide. Users who believe they have been affected should contact Dexcom for further information.
The recalled product
- Product
- Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog Number: SW14245 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ Androind CGM App Component: Dexcom ONE+ Continuous Glucose Monit
- Manufacturer
- Dexcom, Inc.
- Hazard
- alert-failure
- glucose-monitoring-failure
- hypoglycemia-risk
- hyperglycemia-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: UDI: SW14245 - 00386270004314
Distribution
Distributed nationwide across the United States.
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