Voluntary medical device correction issued for small subset of FreeStyle Libre 3 sensors
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Key takeaways:
- Abbott issued a medical device correction for some FreeStyle Libre 3 sensors distributed in May.
- The correction was issued due to the potential for incorrect high glucose readings.
A voluntary medical device correction has been issued for a small number of continuous glucose monitoring sensors distributed in the first half of May, according to an industry press release.
Abbott announced a medical device correction for some FreeStyle Libre 3 sensors on July 24. After internal testing, the company stated some sensors from three lots may provide incorrect high glucose readings. The voluntary medical device correction was issued for lot numbers T60001948, T60001966 and T60001969.
Lot and serial numbers can be found on the bottom of the carton’s packaging for unopened sensors or displayed within the FreeStyle Libre 3 app or reader for sensors already in use. The device correction affects only the sensor and does not affect the app or reader.
People who have a sensor from one of the three affected lot numbers are asked to visit www.freestyleconfirm.com, select “confirm sensor serial number,” and enter their serial number to determine whether their sensor is affected by the medical device correction. If their sensor is affected, people should immediately discontinue using it and dispose of any other affected sensors. Users also need to enter their contact information so they can receive a free replacement sensor from Abbott.
Anyone who experiences symptoms that do not match their sensor glucose reading or who believes their reading may be inaccurate should conduct a fingerstick test. The FreeStyle Libre 3 reader includes a built-in blood glucose meter than can check glucose at any time.
"We sincerely regret the disruption this may have on our customers," Jared Watkin, executive vice president of Abbott’s diabetes care business, said in the release. "We’re actively working with the U.S. FDA and distributors, as well as providing information to affected customers, who will receive replacements at no charge as quickly as possible."
Anyone who has questions can visit www.freestyleconfirm.com or call Abbott’s customer service line at 1-833-815-4273 seven days a week, from 8 a.m. to 8 p.m. Eastern time, excluding holidays.
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