Abbott Issues Voluntary Medical Device Correction for Small Number of Freestyle Libre 3 Sensors

Abbott has initiated a voluntary medical device correction for a small number of FreeStyle Libre 3 sensors distributed in the United States during the first half of May 2024.

 

The FreeStyle Libre 3 system includes a sensor, reader, and app. This medical device correction impacts the sensor only. The FreeStyle Libre 3 reader and app are not impacted. There is no impact for users who live outside of the U.S. or use other FreeStyle Libre products

 

The issue affects FreeStyle Libre 3 sensors from the T60001948, T60001966, and T60001969 lot numbers. Consumers wearing an affected FreeStyle Libre 3 sensor should immediately discontinue use and dispose of any affected sensors in their possession.

 

“We sincerely regret the disruption this may have on our customers,” said Jared Watkin, executive vice president of Abbott’s diabetes care business. “We’re actively working with the U.S. Food and Drug Administration and distributors, as well as providing information to affected customers, who will receive replacements at no charge as quickly as possible.”

 

Internal testing determined that some of the sensors from among three lots may provide incorrect high glucose readings, which if undetected may pose a potential health risk for people living with diabetes and can lead to incorrect treatment decisions, such as taking insulin when not required.

 

Consumers are instructed to conduct a fingerstick test using any blood glucose meter if they experience symptoms that do not match the sensor glucose reading or suspect the reading may be inaccurate. The built-in blood glucose meter in the FreeStyle Libre 3 reader may be used to check glucose at any time.

 

To check if a product is affected, visit the FreeStyle Confirm Site to check and confirm if their sensor is affected by this voluntary medical device correction. If the consumer’s sensor is impacted they will need to enter their contact information so Abbott can send them a replacement sensor at no charge.