(NBC CHICAGO) — The Food and Drug Administration issued an alert about a "potentially high-risk issue" regarding malfunctioning Abbott glucose sensors that have been linked to more than 700 serious injuries and 7 deaths, with patients advised to "immediately" discontinue using the products.
The alert, dated Dec. 2, says Abbott Diabetes Care issued a letter to distributors, health care providers and affected customers after it found certain FreeStyle Libre3 and FreeStyle Libre3 Plus sensors gave incorrect low glucose readings.
"If undetected, incorrect low glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses," a message marked "Urgent Medical Device Correction" read on the product's website.
"These decisions may pose serious health risks, including potential injury or death, or other less serious complications," the message said.
The issue applies to approximately 3 million sensors distributed in the U.S., Abbott said. Customers can verify if their sensor serial number if part of the recall here, and a full list of instructions to follow for patients and health care providers can be found here.
As of Nov. 14, Abbott reported 736 serious injuries, and 7 deaths potentially linked to the issue. According to a media release, 57 of the injuries were in the U.S. All the deaths outside of the U.S., Abbott said in a release.
The sensors are meant to provide continuous glucose monitoring for people aged four and older with diabetes. It is intended to detect trends, track patterns and aid in the detection of hyperglycemia and hypoglycemia.
In a statement sent to NBC Chicago, Abbott said the company has contacted customers about the medical device correction with instructions about how to request replacement.
"No other Libre products are impacted," Abbott said.
