
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
Home Security Frameworks with Shrewd Elements - 2
These four astronauts could soon travel farther from Earth than anyone has gone before - 3
Setbacks in Texas and elsewhere put Republicans' redistricting hopes in doubt as key deadlines loom - 4
10 High priority Contraptions for Tech Aficionados - 5
When darkness shines: How dark stars could illuminate the early universe
Best Veggie lover Dinner: What's Your Plant-Based Pick?
Common ADHD medication prescribed in childhood may protect against risk of psychosis
Palestinian infant freezes to death in Gaza as Israel keeps blocking aid
21 Things You Ought to Never Tell Your Childless Companion
Moderna to complete US mRNA manufacturing network with $140 million investment
Astronauts beam home Christmas wishes from International Space Station: 'I think we may be orbiting a little higher than Santa' (video)
Before Cheap Cars Were Common, This Fiat Changed Everyday Life for Millions
4K televisions for Extreme Film Watching Experience
The 15 Best Business visionaries Under 40













