Dexcom has been hit by a major safety issue for an Android version of its G6 continuous glucose monitoring system app, leading the FDA to issue its most serious recall notice.
A “software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications," according to a Class I notice posted by the regulatory agency.
This could cause serious safety issues, including “in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS)," the FDA notes.
The recall began in late August but was only recently published by the FDA. Android users have since been asked to update the app to overcome the issue.
Dexcom has been hit by several technical issues for its products this year. In June, the company sent an urgent notice to customers that it would need to replace some of the receivers that link with its CGM systems due to a defective speaker.
This came after several of the devices failed to provide audio alarms of unhealthy blood sugar levels.