Dexcom Issues Serious Software Correction for G6 and G6 Pro Continuous Glucose Monitoring Apps

Dexcom Inc. has issued a critical software correction for its Dexcom G6 and G6 Pro Continuous Glucose Monitoring (CGM) Android application in the United States, following the identification of a software bug that could pose serious health risks if left uncorrected.

The correction affects Dexcom G6 and G6 Pro Android US CGM App version 1.15.0 only. According to the U.S. Food and Drug Administration (FDA), this action has been classified as the most serious type of medical device recall, although it does not involve removing devices from use or sale. Instead, it requires users to update the software immediately.

What Went Wrong

Dexcom identified a bug in app version 1.15.0 that can cause the application to terminate unexpectedly. If this occurs, users may not receive real-time glucose readings, alarms, or alerts. This failure could result in missed detection of hypoglycemic (low blood sugar) or hyperglycemic (high blood sugar) events, potentially leading to severe injury or death if users are unaware the app has stopped functioning.

Affected Product

• Product Name: Dexcom G6 Continuous Glucose Monitoring System – G6 and G6 Pro Android US CGM App
• Affected Version: 1.15.0 only
• Unique Device Identifier (UDI): SW11678 (00386270000811)

Dexcom has confirmed that all affected devices have now been updated to resolve the issue, and the correction does not apply to users on other app versions.

Actions for Users

On September 18, Dexcom sent an Urgent Medical Device Correction notice to all affected customers, advising them to:

1. Open the Google Play Store
2. Search for the Dexcom G6 app
3. Install the latest available version
4. Open the updated app to resume normal use

Users who need assistance are advised to contact Dexcom Technical Support at 1-844-478-1600.

Dexcom also announced that app version 1.15.0 will no longer function after October 6, 2025, making the update mandatory for continued use.

Health Impact

While the FDA warns that continued use of the affected software could lead to serious adverse health outcomes—including severe hypoglycemia, hyperglycemia, or death—Dexcom reported that no serious injuries or deaths had been recorded as of September 16.

About the Device

The Dexcom G6 Continuous Glucose Monitoring System is a real-time CGM device that transmits glucose readings every five minutes to a compatible smart device or Dexcom receiver. The Android CGM app allows users to monitor glucose levels, trends, and alerts remotely.

Contact Information

U.S. customers with questions or concerns about this correction can contact Dexcom Technical Support at 1-844-478-1600.

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