
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
Mont Blanc road tunnel reopens to traffic after 15 weeks of repairs - 2
Find the Effect of Web-based Entertainment on Psychological wellness: Exploring the Advanced Scene Securely - 3
Catch the moon dancing with bright star Regulus tonight - 4
Peloton recalls more than 800,000 bikes after broken seat posts injure users - 5
Prehistoric wolf’s gut frozen in time reveals an ice age giant
The Developing Nearby Food Development and Its Advantages
Scientists dove hundreds of feet into the ocean and found creatures no human has ever seen. Our trash beat us there
The 10 Most Significant Virtual Entertainment Missions
Surging measles cases are 'fire alarm' warning that other diseases could be next
BHP liable for 2015 Brazil mine disaster: UK court
Israeli forces kill one person in series of attacks on southern Lebanon
Who was Haytham Ali Tabatabai, Hezbollah's military leader killed by Israel?
I'm a hypnotherapist who helps day traders who are losing money. Here's why I think hypnosis works.
Building an Individual Brand: Illustrations from Forces to be reckoned with












