Abbott has announced a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States. The company initiated this action after internal testing found that some sensors may give incorrect low glucose readings.
"If undetected, incorrect low glucose readings over an extended period may lead to incorrect treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses. These decisions may pose serious health risks, including potential injury or death, or other less serious complications," the company stated.
The manufacturing issue is linked to one production line among several that produce these sensors. Abbott reports that it has identified and resolved the cause of the problem and continues to manufacture sensors for both replacement and new orders. The company does not anticipate significant supply disruptions.
About three million affected sensors were distributed in the U.S., but Abbott estimates that about half have already expired or been used. Globally, there have been 736 reports of severe adverse events related to this issue, with 57 reported in the United States. There have also been seven deaths associated with this problem worldwide; none occurred in the U.S.
Consumers using FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensors are advised to visit www.FreeStyleCheck.com to determine if their sensor is affected by this correction. "Abbott will replace any potentially affected sensors at no charge. Detailed instructions on how to check sensors and request a replacement are available on www.FreeStyleCheck.com."
If consumers find they are using an impacted sensor, they should stop using it immediately and dispose of it properly. For those whose sensor readings do not match their symptoms or expectations, Abbott recommends using a blood glucose meter or the built-in meter in the FreeStyle Libre 3 reader before making treatment decisions.
For further information or assistance, customers can visit www.FreeStyleCheck.com or call Abbott’s customer service at 1-833-815-4273 from 8 a.m. to 8 p.m. Eastern Time daily. Live chat support is available at https://www.freestyle.abbott/us-en/support/contact-us.html around the clock.
The correction does not affect FreeStyle Libre 3 readers, mobile apps, other Libre products (including FreeStyle Libre 14 day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, or Libre Pro sensors), nor any other Abbott biowearables.
Abbott is also issuing similar corrections in other countries where these products are distributed.
"Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Connect with us at Abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube."
