Faulty glucose monitors linked to 7 deaths and more than 700 injuries, FDA warns

"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 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 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."

Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors can provide incorrect low glucose readings that may cause dangerous treatment decisions. Incorrect low readings can lead people with diabetes to consume excessive carbohydrates or skip or delay insulin, posing serious health risks including injury or death. The issue affected about three million sensors in the U.S. from a single production line; about half had expired or been used. Abbott reported seven deaths worldwide and 736 serious adverse events, with 57 injuries in the U.S. Abbott notified customers, identified and resolved the affected lot, and offers replacements via FreeStyleCheck.com. The FDA advises stopping and discarding affected sensors; no other FreeStyle Libre products are affected.

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