Faulty glucose monitors linked to 7 deaths and more than 700 injuries, FDA warns

The U.S. Food and Drug Administration is warning people to stop using certain types of glucose monitoring sensors after the company that manufactures the devices, Abbott Diabetes Care, said the devices were linked to seven deaths and more than 700 injuries.

Some FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may provide inaccurate low glucose readings, FDA officials said this week. Such readings over a long period of time can lead people with diabetes to make poor treatment decisions, such as eating too many carbohydrates or skipping or delaying their insulin dose.

“These decisions may pose serious health risks, including potential injury or death,” the FDA said in the warning.

Sensors are devices that measure glucose levels in the fluid just under the skin to provide real-time measurements of blood sugar. Information from the sensor is sent wirelessly to a device or phone.

The warning affected nearly three million sensors on a single production line in the United States, Abbott officials said in a statement. The company added that about half of these devices have expired or are in use. As of November 14, the company reported seven deaths and 736 serious adverse events worldwide. There were no deaths in the USA, where 57 people were injured.

Abbott notified all customers about the problem. The company said it identified and fixed the problem in the affected production batch.

The FDA said people should stop using the affected sensors and throw them away.

The issue involved FreeStyle Libre 3 sensors with model number 72080-01 with unique device identifiers 00357599818005 and 00357599819002. It also contained FreeStyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01 and their unique device identifiers. 00357599844011 and 00357599843014.

People can visit www.FreeStyleCheck.com The company told them to check if their sensors were potentially affected and request replacement. No other FreeStyle Libre products are affected.

The Associated Press receives support from the Health and Science Department, the Howard Hughes Medical Institute Department of Science Education and the Robert Wood Johnson Foundation. AP is solely responsible for all content.