The recall involves hundreds of thousands of continuous glucose monitors with potentially faulty alarms.
|Dexcom won FDA approval last year for its Dexcom G5 mobile continuous glucose monitoring (CGM) system, which sends glucose data directly to a smartphone. (Image courtesy of Dexcom)|
Dexcom has announced a massive and serious continuous glucose monitors recall, involving more than 260,000 devices with alarms that may fail to sound.
Rather than asking customers to return the devices, the company sent patients a February 23 letter listing instructions on how to test the receiver's audio alert. The company said that customers had complained that the speakers failed to provide audible alerts and alarms "in some or all circumstances."
FDA has designated the recall as Class I. The recall covers all models and lots of the company's G4 Platinum receivers and the newest addition to the line--the G5 Mobile receiver, which FDA approved in August. The devices were manufactured between July 29, 2011 and March 10, 2016.
Dexcom notified customers about this potential issue after receiving customer complaints about the receivers' speaker component. Specifically, the speaker failed to properly provide audible alerts and alarms in some or all instances.
Dexcom could not be immediately reached for more information about the cause of the alarm failure.
The systems monitor the blood sugar level of adult and pediatric patients with type 1 or type 2 diabetes. They include a sensor that is placed under the skin to measure blood glucose readings that are sent to a hand-held receiver. The CGMs are used in combination with standard home glucose monitoring devices in the management of diabetes.
Too much blood glucose can lead to blindness and kidney failure. When blood glucose levels fall too low (hypoglycemia), patients may suffer confusion, disorientation, loss of consciousness, coma, or seizure. Keeping hypoglycemia at bay overnight is a high priority, especially for parents of children who have the disease.
The recall covers 263,520 CGMs in the U.S., and a total of 270,111 worldwide, according to FDA. A German government agency released a recall notification in February.
The G5 is the first fully mobile CGM system for adults and children as young as 2 years of age, according to the Dexcom website. It sends glucose data directly to a smartphone app on iOS-enabled devices. Up to five patient-designated followers can receive data from the G4 and G5 monitors. When FDA approved the G5 for smartphones, the company said that Android applications would follow in early 2016.
Dexcom is also working with Google to launch a next-generation continuous glucose monitor device, which company officials hope to have launched in 2018. This device would be smaller and less expensive than CGM systems available today. By 2020 to 2021, the company hopes to have a disposable sensor that is like a tiny bandage on the skin.
Dexcom and Google announced the continuous glucose monitor partnership last year. It was described at the time as a marriage of Google's miniaturized electronics platform with Dexcom's sensor technology.
Other companies jockeying for position in the CGM race include Animas Corp., which won FDA approval for its Animas Vibe insulin pump and CGM in December 2014. Animas pairs with the Dexcom 4 Platinum system for type 1 diabetes patients. Last spring, Medtronicunveiled a collaborationwith Samsung related to the development of mobile diabetes apps for Samsung technology. FDA cleared Medtronic's MiniMed Connect technology, which enables smartphone users to view data from the firm's CGM and insulin pumps, in early June.
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