FDA classifies this as a Class I recall, which means using the device could result in adverse health effects or death.
Dexcom Inc., has recalled its G4 Platinum and G5 Mobile continuous glucose monitoring system receivers, due to complaints that the audible alarm may not activate the receiver when patients experience low or high glucose levels. This is an essential feature of the device that protects persons with type 1 and type 2 diabetes from experiencing hypoglycemia or hyperglycemia.
The recall affects 263,520 unites made between July 2011 and March 2016, which were distributed starting in October 2012.
FDA classifed this as Class I recall and posted a notice on its website Monday. As of this morning, Dexcom’s consumer notification stated, “Dexcom is working on implementation of an improved speaker for our receivers.”
A Class I recall occurs when there is a reasonable probably that continuing to use the product will result in serious adverse health consequences or death.
Without the alarm sounding, persons with diabetes may not know they have low or high blood sugar, and thus could experience an episode of hypoglycemia or hyperglycemia that could end with hospitalization or, in more serious circumstances, death.
The recall follows a February 23, 2016, customer notification letter with instructions on how to test their CGM device to ensure it the alarm was working properly.
Models affected are the Dexcom G4 PLATINUM Receiver, the Dexcom G4 PLATINUM (Pediatric) Receiver, the Dexcom G4 PLATINUM (Professional) Receiver, the Dexcom G4 PLATINUM Receiver with Share, the Dexcom G4 Platinum (Pediatric) Receiver with Share, and the G5 Mobile Receiver Model.
Healthline’s Mike Hoskins, a person with type 1 diabetes who is a Dexcom user, credited the company with its handling of the February notice, including its initial announcement during an investor call.
Hoskins wrote, “As a customer, I really appreciate how Dexcom handled this—using the investor call, social media channels, proactive outreach to the (diabetes online community), a special site online, and its own call center and certified mailing to tackle this potential problem head on.”