Dexcom Inc. recently issued an urgent correction for its Dexcom G6 Continuous Glucose Monitoring (CGM) System’s Android US CGM App, version 1.15.0. This correction targets a critical bug that could affect patient safety. Clinical, quality, and regulatory teams, as well as end-users of this device, should take immediate action.
What changed?
The correction addresses an issue with the Dexcom G6 and G6 Pro Android US CGM App, version 1.15.0. This bug may cause the app to terminate unexpectedly, resulting in the failure to deliver estimated glucose readings or essential alerts. As a result, users could miss vital warnings related to blood sugar trends, potentially leading to hyperglycemic or hypoglycemic events. This situation prompted the FDA to classify the action as a Class I recall, the most serious type, as the failure to address the defect may result in severe health consequences or even death.
On September 18, 2023, Dexcom began notifying impacted customers through an urgent medical device correction. The company strongly recommends all users of the Android US CGM App version 1.15.0 upgrade to the latest version immediately to mitigate these risks. The company clarified that this issue does not pertain to other app versions or devices outside this specific app version and platform.
Who is affected?
This correction specifically impacts users of the Dexcom G6 Continuous Glucose Monitoring System and G6 Pro models operating the Android US CGM App version 1.15.0. Customers who rely on the app’s real-time glucose readings and alerts on compatible smart devices or the Dexcom receiver must ensure they are using the updated version to avoid potential issues.
The Unique Device Identifier (UDI) for the affected product is SW11678: 00386270000811. Users can verify their app version in their smart device settings or by consulting the app interface itself.
Manufacturer response and recommended actions
Dexcom Inc. is taking corrective actions to address the issue and has resolved the problem as of this announcement. Affected users are advised to update their app as follows:
- Open the App Store or Google Play Store on your compatible smart device.
- Search for the Dexcom G6 app.
- Download and install the latest version.
- Launch the app and confirm proper functionality.
- For any additional guidance or technical support, contact Dexcom Technical Support at 1-844-478-1600.
Importantly, app version 1.15.0 will no longer function after October 6, 2025. This reinforces the urgency for users to transition to the updated app version immediately.
Device intended purpose and safety information
The Dexcom G6 Continuous Glucose Monitoring System is designed to provide real-time glucose data every five minutes directly to a compatible smart device or Dexcom receiver. It aids in monitoring trends in glucose levels and supports timely medical intervention. However, due to the identified app malfunction, users relying on version 1.15.0 risk missing critical alerts, alarms, or glucose value updates. To date, Dexcom has not reported any associated serious injuries or fatalities related to the identified issue.
Regulatory resources and additional information
For questions or concerns related to this correction, affected users or healthcare professionals should reach out to Dexcom Technical Support at 1-844-478-1600.
The FDA emphasizes the importance of using the Unique Device Identifier (UDI) system to facilitate the tracking, reporting, and correction of medical device issues. The UDI for the affected Dexcom product is SW11678: 00386270000811.
Adverse reactions or quality issues associated with the Dexcom G6 device should be reported to the FDA using its MedWatch program for safety information and adverse event reporting.
Conclusion
Dexcom’s prompt action to address the bug in the Android US CGM App version 1.15.0 underpins the importance of maintaining patient safety in medical device software. Users must update their apps without delay to ensure the continued performance and safety of their Dexcom G6 systems. Stakeholders are encouraged to stay informed about any further notifications by following updates from the FDA and Dexcom Inc.
Disclaimer
The information provided in this article is intended for informational purposes only and does not constitute legal or medical advice. Stakeholders should consult relevant regulatory and healthcare professionals for further guidance.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/continuous-glucose-monitoring-software-correction-dexcom-issues-correction-dexcom-g6-and-g6-pro