Dexcom’s recalls relate to its Dexcom One and One+ offerings and the G6 and G7 CGMs. The One and One+ systems, which are mainly the company’s commercial CGM offering outside the U.S., feature the established G6 and G7 sensors along with other components such as an applicator and receiver.
According to the FDA, Dexcom’s recall came as a result of a potential issue with the receiver component. The reason centered around defective foam or an assembly error that may cause the receiver speaker to lose contact with the printed circuit board. FDA classified the cause as a “nonconforming material/component.”
Dexcom says the issue may lead to missed audible alerts for low or high blood glucose values. Missed alerts can lead to untreated hypoglycemia or hyperglycemia, which can lead to seizures, vomiting, loss of consciousness or death.
The company issued an urgent medical device correction notice on May 12. It then issued an update with actions for consignees to take. It instructed customers to contact the company’s technical support if they have an affected receiver to coordinate a return for the affected device and a no-charge replacement. Regardless of whether the device is affected, Dexcom recommends regular testing of the speaker function.
Units potentially impacted by the issue amount to 703,687, according to the FDA. (This article previously listed the total number of affected products at around 2 million. The FDA updated its recall listing to reflect that the number has decreased.)
Dexcom statement
A spokesperson issued the following statement on behalf of Dexcom:
In rare circumstances, certain Dexcom CGM receivers may experience issues with audio alerts and alarms due to the speaker not functioning as intended. This recall does not impact users who use Dexcom mobile apps as the display device for their glucose values, alerts and alarms, which constitutes a majority of our users globally. For the affected receivers which have been distributed, the reported incidence rate is 0.015%.
We are actively working with local regulatory agencies, and on May 12 began notifying users that may be impacted to check if their device is affected. If the user has an affected device, Dexcom will provide a no-cost replacement. Customers can check if their receiver is impacted at https://www.dexcom.com/checkreceiver.
