The U.S. Food and Drug Administration (FDA) has reported that faulty glucose monitors from Abbott Diabetes Care may be linked to at least seven deaths and hundreds of serious injuries. These concerns have prompted the FDA to issue an “early alert” regarding certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus devices.

The FDA’s alert follows Abbott’s internal testing, which revealed that some of these devices might provide inaccurate low glucose readings. Approximately 3 million of these devices are affected, with the issue traced back to a specific production line.

“Extended exposure to incorrect low glucose readings can result in improper treatment decisions for diabetes patients, such as consuming too many carbohydrates or delaying insulin doses. These errors could lead to significant health risks, including potential injury or death, as well as other complications,” Abbott stated in a recent press release.