Dexcom warns on malfunctioning alarms in latest CGM, German agency discloses

Sensor (1), transmitter (2), and a smartphone showing glucose data (3) -- Courtesy of Dexcom

Continuous glucose monitor company Dexcom has hit a stumbling block. Some of its devices, including the G5 receiver for a system that just launched last fall, are not providing the audio alarms and warnings as expected. The company's patch-based CGMs connect to dedicated receivers or smart devices to offer continuous glucose tracking for diabetics.

According to a notice sent to customers in February, it said that the audio alarms and warnings on some of its continuous glucose monitor devices may not function in the event of a severe hypoglycemic or hyperglycemic event. A German regulatory agency posted news of the notice on April 7.

Dexcom ($DXCM) hasn't said it's conducting a recall of the affected devices, instead it advises customers to "periodically test the alarms and alerts on your receiver to make sure that your alarms and alerts are functioning properly." It added, particularly "if the receiver gets wet or is dropped."

The company is chalking up the issue to a deficiency in the speakers in its receivers. It said it's working on a way to implement improved speakers in the receivers.

It said it has "noticed an increase in complaints for audible alarms and alerts" associated with Dexcom receivers including Platinum, Platinum Pediatric, Platinum Professional, G4 Platinum with Share, G4 Platinum with Share Pediatric as well as the G5. Although the G5 system is designed specifically to obviate the need for a dedicated receiver since its transmitter connects directly to a smart device, it can be used with a receiver.

Dexcom has had a meteoric rise on Wall Street in recent years as it staked out a niche as a smart device-savvy CGM maker that has a particular appeal among children and teens with Type 1 diabetes--and their parents, since connectivity enables parents to easily track kids remotely.

Dexcom G4 Platinum System--Courtesy of Dexcom

The company's shares peaked last fall after it disclosed a major, ambitious deal with Verily, the med tech arm that falls under Google's parent company Alphabet ($GOOG), to develop miniaturized CGMs--including a disposable one the size of a Band-Aid. But it's been on a slide since, with a share price that's down about one-third to around $67 from a September high of over $100.

- here is the Dexcom customer notice
- and here is the BfArM disclosure (in German)