This correction comes as a result of an issue that led to hundreds of severe adverse events, including seven deaths.
Abbott — one of the largest diabetes tech companies in the world — initiated the correction after determining that some of the continuous glucose monitor (CGM) sensor devices may provide incorrect low glucose readings. If undetected, such readings over an extended period can lead to incorrect treatment decisions for people with diabetes.
Incorrect treatment decisions could lead to excessive carbohydrate intake or skipping or delaying insulin doses. Such decisions can present serious health risks, including potential injury or death, in addition to other, less serious complications.
The action involves approximately 3 million Libre 3 and Libre 3 Plus sensors in the U.S. from that production line. Abbott estimates that about half have expired or been used. Globally, the company received reports of 736 severe adverse events, with 57 coming in the U.S. It reports the seven deaths, with none coming in the U.S., potentially associated with the issue.
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Abbott said it identified and resolved the cause of the issue, which relates to one production line among several making Libre 3 and Libre 3 Plus sensors.
The company continues producing sensors to fulfill replacement and new orders and expects no significant supply disruptions.
FreeStyle Libre 3 is the company’s latest-generation CGM and has been on the market for years after receiving FDA clearance in May 2022. Libre 3 Plus is Abbott’s version of the sensor that pairs with insulin delivery systems.
Abbott said consumers should visit www.FreeStyleCheck.com to confirm whether the issue affects their sensor. It intends to replace any potentially affected sensors at no charge. Consumers wearing or in possession of a potentially impacted sensor should immediately discontinue use and dispose of it. Consumers should use a blood glucose meter or the built-in meter in the FreeStyle Libre 3 reader to make treatment decisions when sensor readings don’t match symptoms or expectations.
The issue does not affect Libre 3 readers and mobile apps. No other Libre products (Libre 14-day, Libre 2, Libre 2 Plus or Libre Pro sensors) or other Abbott biowearables are impacted.
