Patients are being warned to stop using some glucose monitors made by Abbott Diabetes Care after the company found malfunctioning sensors may be linked to hundreds of adverse events and several deaths, the Food and Drug Administration said Tuesday.
Internal testing by Abbott found that some sensors in certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus devices may provide incorrect low glucose readings, the company said in a news release . Abbott said it had received reports of 736 adverse events potentially linked to the issue. Fifty-seven were reported in the United States. Seven deaths, none of which were in U.S., were potentially associated with the sensor error, Abbott said. The FDA referred to the error as a "potentially high-risk issue" in a news release .
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