Dexcom’s Recall of Certain CGM Receivers is Class I

Dexcom has provided an update related to a recall involving its continuous glucose monitor (CGM) components.

The recall involves receivers for the company’s G6, G7, ONE, and ONE+ CGM devices. Some of these receivers were identified to have a problem with the speaker, causing it to fail to make an alert sound when blood sugar is dangerously low or high. The reason centered around defective foam or an assembly error that can cause the receiver speaker to lose contact with the printed circuit board.

Using the affected product can cause seizures, vomiting, loss of consciousness, and death. There have been at least 56 reported injuries due to the issue, and no reports of death.

The Dexcom G6, G7, ONE, and ONE+ receivers are part of continuous glucose monitoring systems that help people with diabetes track glucose levels in real time. The receiver issues alerts when blood sugar is too high or too low. These devices may be used at home or in healthcare facilities.

The recall is Class I—the most dangerous type—and involves removing certain devices from where they’re used or sold.

The company’s update recommends users check the product list to see if their product is affected and contact the company for a replacement. Users should test their speaker regularly, and whether or not it’s affected should test the speaker every time they charge it, Dexcom urged.