New safety alert for certain continuous glucose monitoring systems
Glucose readers in the FreeStyle Libre product family have the potential for battery swelling and overheating if not properly stored, charged, or used.
Readers used as part of the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems have the potential for battery swelling and overheating, the FDA said in an April 3 safety notification.
Abbott, the manufacturer, initiated a voluntary medical device correction in February to emphasize the device instructions due to a limited number of user reports worldwide (0.0017%) that the reader's lithium-ion battery swelled, infrequently overheated, or, in very rare cases, sparked or caught fire, according to the FDA. This issue does not affect any FreeStyle Libre sensors.
The company is not physically recalling any readers, and customers may continue to use their readers, which remain safe when properly stored, charged, and used only with their accompanying USB cable and power adapter, as outlined online.