Dexcom, Inc. is recalling three models of glucose monitoring systems because the audible alarm may not activate in the receiver piece when low or high glucose levels (hypoglycemia or hyperglycemia) are detected. The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Relying on these devices for notification of low or high blood sugar (glucose) could result in serious adverse consequences, including death, because the auditory alarm may not sound and users might not be notified of low or high blood sugar.
The recall includes all models and lot numbers of Dexcom’s G4 Platinum receivers and G5 Receivers. They were distributed from October 2012 to March 2016. A total of 263,520 units are recalled nationwide. The Dexcom Continuous Glucose Monitoring Systems are used to monitor the blood sugar levels of adult and pediatric patients with type 1 or type 2 diabetes. These glucose monitoring systems include a sensor that is placed under the skin to measure blood glucose readings that are sent to a hand-held receiver. They are used in combination with standard home glucose monitoring devices for diabetes management.
Customers should follow Dexcom’s instructions to test the audio alert on the receiver, and then contact Dexcom if the alert does not work properly.