(NewsNation) — At least seven deaths and hundreds of serious injuries may be tied to malfunctioning glucose monitors manufactured by Abbott Diabetes Care, the U.S. Food and Drug Administration says.
The agency, citing internal testing by Abbott, has issued an “early alert” that some FreeStyle Libre 3 and FreeStyle Libre 3 Plus devices may provide incorrect, low glucose readings. About 3 million devices are affected by the issue, which was traced to one production line.
“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 said in a recent news release.
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As of November, Abbott said, the company had received reports of 736 “severe adverse events,” including 57 in the United States, potentially related to the issue. The seven deaths associated with the problem have all been outside the U.S., Abbott said.
The company urges potentially affected consumers to visit www.FreeStyleCheck.com. Abbott will replace any sensors that fall all under the “medical device correction” announcement.
The company has identified the source of the issue and said it does not expect significant supply disruptions.
