FDA reports 7 deaths caused by defective glucose monitors implanted in people's arms

The Food and Drug Administration has issued a warning urging patients to stop using specific glucose monitoring devices after a series of malfunctions were connected to more than 700 serious injuries and seven fatalities.

Abbott Diabetes Care, the manufacturer of the affected monitors, stated in a press release that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may show falsely low glucose readings. The company reported a total of 736 severe adverse events globally, with 57 occurring in the United States. None of the seven deaths reportedly occurred within the U.S.

Approximately three million devices are impacted. According to the FDA, prolonged exposure to inaccurate low glucose readings can result in dangerous treatment decisions for people with diabetes, such as consuming excess carbohydrates or delaying insulin administration.

These errors could lead to serious health consequences, including injury or death, the FDA emphasized. Users of FreeStyle Libre 3 or FreeStyle Libre 3 Plus devices are advised to verify their model numbers and unique device identifiers to determine whether their sensors are affected.

Abbott confirmed that the problem was traced to a single production line and has since been addressed. The company does not anticipate major supply disruptions as a result of the issue.

The FDA recommends that patients immediately stop using and safely discard any affected sensors. About 38.4 million people in the U.S.roughly one in tenhave diabetes, making safe glucose monitoring essential. Diabetes remains a leading cause of death in the country.

Customers can check if their sensors are affected at www.FreeStyleCheck.com. Abbott will replace any impacted sensors at no cost.

Author: Noah Whitman