Dexcom recalled its continuous glucose monitoring systems, which are used to monitor blood sugar levels of patients with type 1 or 2 diabetes.
The FDA noted that the audible alarm in the system might not activate when it detects hypoglycemia or hyperglycemia. If the alarm does not sound, patients could experience serious adverse events, including death.
The recall affects all model numbers and lot numbers of the following devices: Dexcom G4 PLATINUM Receiver, Dexcom G4 PLATINUM (Pediatric) Receivre, Dexcom G4 PLATINUM (Professional) Receiver, Dexcom G4 PLATINUM Receiver with Share, Dexcom G4 PLATINUM (Pediatric) Receiver with Share and the Dexcom G5 Mobile Receiver.
In the U.S., the recall includes 263,520 units that were manufactured from July 29, 2011, to March 10, 2016, and distributed from Oct. 22, 2012, to March 10, 2016.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.