A leading manufacturer of glucose monitoring devices has issued a Class I recall of two of its devices. Dexcom is recalling its G4 Platinum and G5 Mobile Continuous Monitoring Systems (CGM) due to a potentially deadly defect with their alarms.
The devices are supposed to sound an audible alarm if the user's blood glucose has reached a dangerous level. However, Dexcom and the U.S. Food and Drug Administration have discovered that the alarms on the G4 and G5 CGMs tend not to make a sound when they are supposed to.
Under the FDA's guidelines, a Class I recall involves a defect in a medical device that could cause serious injury or death. In this case, not being alerted to a dangerous blood glucose level could lead to a user suffering a serious, even fatal illness.
Dexcom has issued instructions for users to check if their G4 or G5 device is functioning properly. You can read those instructions in an Insulin Nation article about the recall here. If your device fails the test, Dexcom is offering replacement receivers.
Insulin Nation notes that Dexcom has had a reputation as the "gold standard" for glucose monitors and other devices used to treat and study diabetes. Recalls like this one show that, even when a medical device company has a solid reputation, it is still possible for that company to distribute a product with serious defects.
Too often by the time a manufacturer or the FDA issues a recall, many users of adefective device have already suffered serious injury. If this has happened to you or a loved one, you will need the assistance of a skilled products liability attorney to fight for just compensation.