Dexcom is working to replace some of the receivers that link with its continuous glucose monitoring systems due to a defective speaker, after a number of the devices failed to provide audio alarms of unhealthy blood sugar levels.
The hand-held receiver devices offer an optional alternative to the company’s smartphone app, by logging the sensors’ blood sugar readings, displaying trends and delivering alerts through its own touchscreen display.
The company said in an urgent notice to customers (PDF) earlier this month that it has received at least 112 complaints worldwide, as well as 56 reports of severe adverse events—including seizures, loss of consciousness, vomiting and other symptoms related to hypoglycemia or hyperglycemia. Dexcom said that all users recovered.
The issue has been traced back to defective foam or assembly errors that may cause the speaker to lose contact with the device’s circuit board, leading to the missed audio alerts.
The receivers—used with Dexcom’s G7, G6, One and One+ CGMs—can still deliver vibration and visual warnings. The company also said the sensors’ accuracy is unaffected, as are people who use smartphone apps.
Customers were first notified of the problem by the company in mid-May. After Dexcom sent out an update on June 3, the FDA this week elevated the issue to a Class I recall, its most serious designation.
The agency said more than 700,000 of the devices have been distributed internationally, though not all have been affected. Dexcom said the reported incidence rate so far is 0.015%. The company is offering replacements at no charge, based on the device’s serial number.
Dexcom recommends that users still test their speaker on a regular basis, including every time they change their receiver.
The company previously issued correction notices for its G6 receivers in January and February of this year (PDF), saying that some alerts or alarms may be delayed or missed. Dexcom said that issue was fixed with a software update.
Editor's note: This story has been updated with new information from the FDA and Dexcom. The agency revised its count of the number of devices in commerce, down from its previous estimate of more than 2 million total.