Faulty CGMs Linked to Seven Deaths, Hundreds of Injuries

Abbott has issued a medical device correction for certain FreeStyle Libre 3 and Libre 3 Plus continuous glucose monitors after internal testing revealed some sensors may report inaccurately low glucose readings. Such errors can lead people with diabetes to make unsafe treatment decisions, including excessive carbohydrate intake or delayed insulin use, posing serious health risks.

An FDA Early Alert links the faulty sensors to seven deaths and hundreds of serious injuries globally, including cases in the U.S. Abbott has resolved the manufacturing issue and is replacing affected sensors at no cost; consumers can check impact at FreeStyleCheck.com. Public health communicators may want to reinforce guidance on verifying sensor performance and using blood glucose meters when readings conflict with symptoms. Read more from Abbott here.