Continuous Glucose Monitoring Systems Recalled Over Alarm Failure

The FDA has identified this as a Class I recall, the most serious type of recall.

Dexcom Inc. is recalling the Continuous Glucose Monitoring Systems because the audible alarm may not activate in the receiver piece when low, or high, glucose levels are detected.

According to a press release by the FDA, relying on this product for notification of low or high blood sugar could result in serious adverse consequences, including death as the auditory alarm may not sound and users might not be notified of low or high blood sugar.

The device is used to monitor the blood sugar (glucose) level 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 in the management of diabetes.

More in Medical device packaging