Dexcom recalled an Android app for its G6 glucose sensor due to a software problem that could cause the app to terminate unexpectedly.
The issue could cause users to miss alarms, alerts or notifications related to estimated glucose values, according to a Food and Drug Administration database entry posted Oct. 30.
The glucose sensor and the app are still available, but Dexcom required users to update the app to a new version.
Dexcom began the recall on Aug. 28. The FDA designated the event as a Class 1 recall, the most serious kind.
The problem could result in missed detection of a hyperglycemic or hypoglycemic event, including serious conditions such as severe hyperglycemia and diabetic ketoacidosis, according to the recall database entry.
Dexcom sent a notification to customers in September about the software bug, which applies to version 1.15 of the G6 Android app. To use the app, customers must update it to a new version, according to the entry.
A Dexcom spokesperson wrote in an email that the problem was detected before version 1.15 of the app launched broadly and was downloaded by 333 users. The company said all 333 users have since updated to an unaffected app version.
Dexcom has had multiple Class 1 recalls of its glucose sensors this year. In September, the FDA posted a recall of Dexcom’s G7 continuous glucose monitors because of a problem where apps did not display a “sensor failed” alert. Another recall, posted in June, found that receivers associated with multiple Dexcom CGMs may not provide audible alerts due to a speaker problem.
