Dexcom (Nasdaq:DXCM) recently issued an urgent field safety notice in Europe warning of a potential issue with certain G6 receivers.
G6 continuous glucose monitor (CGM) receivers deliver glucose readings and alerts. However, certain devices may experience an issue in which alarms/alerts fail to function as designed. In rare instances, the alarm/alert may be missed or delayed. This occurs with only G6 receivers with the part number MT24078-1 and MT24078-2.
Dexcom said it identified the source of the issue and plans to release a software update to solve the issue. News of the issue with this receiver comes on the heels of a separate FDA notice warning of potential missed alarms and alerts with smartphone-connected diabetes devices, including CGMs.
According to the safety notice, Dexcom G6 receiver users with impacted software reported an issue in a small percentage of devices. They say the receiver may miss or delay alarms/alerts including low/high glucose, urgent low, urgent low soon, rise/fall rate, signal loss and sensor alert notes. CGM glucose values and glucose trend information continue to be displayed on the receiver.
Dexcom recommends that customers, if available, use the G6 app as a primary display device. G6’s transmitter allows simultaneous communication with an iOS or Android device as well as the receiver. This issue does not impact the app.
If using an affected receiver, customers should check CGM glucose values and trends regularly. If they receive an alarm or alert, they should always check their glucose value prior to taking any additional steps. Customers experiencing the missed or delayed alarm/alert issue can correct it by shutting down the receiver and turning it back on. However, if the same triggering conditions occur after the reset, the issue may reoccur.
