
The U.S. Food and Drug Administration is warning people to stop using certain types of glucose monitor sensors after the company that makes them, Abbott Diabetes Care, said the devices were linked to seven deaths and more than 700 injuries.
Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may provide incorrect low glucose readings, FDA officials said this week. Such readings over an extended period may lead people with diabetes to make bad treatment decisions, such as consuming too many carbohydrates or skipping or delaying doses of insulin.
“These decisions may pose serious health risks, including potential injury or death," the FDA said in the alert.
The sensors are devices that measure glucose levels in fluid just beneath the skin to provide real-time measurements of sugar in the blood. Information from the sensor is sent wirelessly to a device or phone.
The warning affects about three million sensors in the U.S. from a single production line, Abbott officials said in a statement. About half those devices have expired or been used, the company added. As of Nov. 14, the company reported seven deaths worldwide and 736 serious adverse events. No deaths occurred in the U.S., where 57 injuries were reported.
Abbott has notified all customers of the problem. The company said it has identified and resolved the issue in the affected production lot.
The FDA said people should stop using affected sensors and discard them.
The problem involved FreeStyle Libre 3 sensors with model numbers 72080-01 with unique device identifiers 00357599818005 and 00357599819002. It also involved FreeStyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01 and unique device identifiers 00357599844011 and 00357599843014.
People can visit www.FreeStyleCheck.com to check if their sensors are potentially affected and request a replacement, the company said. No other FreeStyle Libre products are affected.
——
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
LATEST POSTS
- 1
Vote In favor of Your Favored Keeping an eye on - 2
Yemen’s Aden airport shut by STC-backed transport minister, Saudi source says - 3
Must-Have Wellness Gear: What to Purchase for Successful Exercises - 4
Every year, she thanks the trooper for the arrest that led to her sobriety - 5
Nine in 10 German industrial firms expect Iran war to hit business
The Solution to Flexibility: Developing Internal Fortitude Notwithstanding Misfortune
Vote in favor of Your Number one Smartwatch: Exactness and Style Matter
Dwayne ‘the Rock’ Johnson opens up about being the 'new guy' again — and why this moment feels like a new life
Exploring Being a parent: A Survey of \Bits of knowledge and Guidance for Guardians\ Nurturing Book
State asks High Court to reject challenge to anti-UNRWA laws ahead of Monday hearing
I’m a doctor. Here are 10 science-backed tips to help you get healthier.
Audits of 6 Specialty Mixed drinks
PFAS in pregnant women’s drinking water puts their babies at higher risk, study finds
Hidden Island Cameras Capture Rare Tasmanian Species for the First Time Ever













