Patients are being warned to stop using certain glucose monitors after malfunctioning trackers have been linked to over 700 serious injuries and seven deaths, according to the Food and Drug Administration.
Abbott Diabetes Care, which makes the faulty monitors, found that sensors in certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus devices “may provide incorrect low glucose readings,” Abbott said in a press release.
Abbott reported 736 severe adverse events, 57 of which took place in the U.S., and seven deaths potentially associated with the issue. None of the deaths occurred in the U.S., the company said.
About three million devices are affected, the company said.
If undetected, incorrect low glucose readings over extended periods of time could lead to incorrect treatment decisions for people who have diabetes, including consuming too many carbohydrates or delaying insulin doses, the FDA says.
“These decisions may pose serious health risks, including potential injury or death, or other less serious complications,” the FDA warned.
Anyone using a Freestyle Libre 3 or FreeStyle Libre 3 Plus device is urged to check its model number and unique device identifiers to see if it's impacted, the FDA and Abbott said.
Abbott says it has since resolved the cause of the issue, which was related to one production line among several that make the devices. The company says it does not expect significant supply disruptions as a result of the manufacturing issue.
“Patients should verify if their sensors are impacted and immediately discontinue use and dispose of the affected sensor(s),” the FDA said.
About 1 in 10 people in the U.S., or 38.4 million people, in the U.S. have diabetes, according to the Centers for Disease Control and Prevention. As of 2021, diabetes was the eighth leading cause of death in the U.S.
Customers can visit www.FreeStyleCheck.com to see if their sensor is potentially affected by the issue. Abbott will replace any potentially affected sensors free of charge.
