FDA warns faulty glucose monitors are linked to multiple deaths and hundreds of injuries

The U.S. Food and Drug Administration is warning people to stop using certain types of glucose monitor sensors after the company that makes them, Abbott Diabetes Care, said the devices were linked to seven deaths and more than 700 injuries.

Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may provide incorrect low glucose readings, FDA officials said this week. Such readings over an extended period may lead people with diabetes to make bad treatment decisions, such as consuming too many carbohydrates or skipping or delaying doses of insulin.

“These decisions may pose serious health risks, including potential injury or death,” the FDA said in the alert.

The sensors are devices that measure glucose levels in fluid just beneath the skin to provide real-time measurements of sugar in the blood. Information from the sensor is sent wirelessly to a device or phone.

The warning affects about three million sensors in the U.S. from a single production line, Abbott officials said in a statement. About half those devices have expired or been used, the company added. As of Nov. 14, the company reported seven deaths worldwide and 736 serious adverse events. No deaths occurred in the U.S., where 57 injuries were reported.

Abbott has notified all customers of the problem. The company said it has identified and resolved the issue in the affected production lot.

The FDA said people should stop using affected sensors and discard them.
The problem involved FreeStyle Libre 3 sensors with model numbers 72080-01 with unique device identifiers 00357599818005 and 00357599819002. It also involved FreeStyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01 and unique device identifiers 00357599844011 and 00357599843014.

People can visit www.FreeStyleCheck.com to check if their sensors are potentially affected and request a replacement, the company said. No other FreeStyle Libre products are affected.
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—Jonel Aleccia, AP Health Writer

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