Global health care company Abbott Laboratories has initiated a medical device correction on nearly 3 million glucose-monitoring sensors following internal testing that indicated some sensors may provide incorrect low glucose readings.
The device corrections include the FreeStyle Libre 3 and FreeStyle Libre 3 Plus models in the United States. The FreeStyle Libre 3 system is a continuous glucose-monitoring (CGM) system that includes the sensor and a Libre app. The sensor is typically applied to the back of the patient’s upper arm and automatically streams glucose readings to a smartphone.
According to the company, incorrect low glucose readings over an extended length of time could lead to incorrect treatment decisions for those living with diabetes, including excessive carbohydrate intake or delaying insulin doses….