Abbott Reports 7 Deaths Linked to Glucose Sensor Problem

 Abbott issued a medical device correction for some of its glucose sensors after internal testing found that some sensors may provide false low glucose readings. Hundreds of adverse events and seven deaths worldwide have been linked to the issue.

The correction affects roughly 3 million FreeStyle Libre 3 and Libre 3 Plus sensors in the U.S. that were traced back to one particular production line. About half of these sensors are estimated to be expired or already used, according to the company's announcement.

Abbott said it has received more than 700 reports of severe adverse events across the globe, including 57 in the U.S. All seven deaths occurred outside of the U.S.

Libre 3 readers and mobile apps are not affected.

Incorrect low glucose readings may lead patients with diabetes to make wrong treatment decisions when it comes to insulin administration or dietary choices. When sensor readings don't match symptoms or expectations, patients should instead use a blood glucose meter or the built-in meter in the Libre 3 reader to make treatment decisions, according to Abbott.

Anyone currently wearing an affected sensor or owning one should immediately stop use and dispose of it, Abbott advised. The company also recommended that patients visit its FreeStyleCheck.com website to confirm if their sensor is affected by the correction and for free replacements.

Other FreeStyle Libre products -- such as Libre 14 day, Libre 2 and 2 Plus, Libre Pro sensors, and Abbott biowearables -- are not affected by the issue.

Another batch of FreeStyle Libre 3 sensors were recalled in 2024 due to risk for inaccurate high glucose readings. That recall was linked with two injuries.

https://www.medpagetoday.com/publichealthpolicy/productalert/118685