Abbott begins medical device correction for certain glucose monitors in US
Abbott Park, III: Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States after internal testing determined that some sensors may provide incorrect low glucose readings.
If undetected, incorrect low glucose readings over an extended period may lead to incorrect treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses. These decisions may pose serious health risks, including potential injury or death, or other less serious complications.
Abbott has identified and resolved the cause of the issue, which relates to one production line among several that make Libre 3 and Libre 3 Plus sensors.
The company continues to produce Libre 3 and Libre 3 Plus sensors to fulfill replacement and new orders and does not expect significant supply disruptions, the release stated.
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This action involves approximately 3 million Libre 3 and Libre 3 Plus sensors in the U.S. from that production line, about half of which are estimated to have expired or been used.
Globally, Abbott has received reports of 736 severe adverse events (57 in the U.S.) and seven deaths (none in the U.S.) potentially associated with this issue.
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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 company said.
FreeStyle Libre 3 readers and mobile apps are not impacted. Additionally, no other Libre products (FreeStyle Libre 14 day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, or FreeStyle Libre Pro sensors) or Abbott biowearables are impacted.
