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
Israel reports killing another senior Iranian oil official - 2Israeli lawmakers pass bill reviving death penalty for terrorists
- 3This Flashy Old-School Design Trend From Italy Still Has A Place In Modern Kitchens
- 4German inflation soars to 2.7% in March as Iran war drives up prices
- 5Health officials report 14 Legionnaires' disease cases in Florida, gym connection suspected
- Mexico says a third of 130,000 missing people might be alive, fueling criticisms by families
- South Carolina's measles outbreak reaches 434 cases
- NASA's Perseverance Mars rover could break the record for miles driven on another planet
- Revealing the Incomparable Realms: An Excursion through Power and Inheritance
- The most effective method to Move toward Compensation Conversations for Cutting edge Practice Enrolled Attendants
- Record-breaking flu hospitalizations in New York in a single week: Health officials
- CDC changes kids' vaccine schedule, removing universal recommendation for some shots
- Study finds humans were making fire 400,000 years ago, far earlier than once thought
- Find Successful Magnificence Items for Sparkling Skin
