Abbott issues US device correction for some glucose monitors over faulty readings risk

Audio By Carbonatix

Enlarge

(Corrects paragraph 3 to say that none of the deaths occurred in the U.S.)

(Reuters) -Abbott Laboratories said on Monday it has begun a correction in the United States for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose monitoring sensors after internal testing showed some units may report falsely low glucose readings.

About 3 million sensors are affected in the U.S., roughly half of which are estimated to have expired or already been used, the company said.

Abbott has received 736 reports globally of severe adverse events and seven deaths that may be linked to the issue. None of the deaths occurred in the U.S.

The problem, tied to one production line, could lead to incorrect treatment decisions for people with diabetes, including excessive carbohydrate intake or missed insulin doses, posing serious health risks, the company said.

A correction is an action to address a problem with a product already on the market or in use without physically removing it from circulation.

Last year, Abbott issued a similar correction for a small number of FreeStyle Libre 3 sensors in the United States that could report inaccurately high glucose readings.

Abbott said it has resolved the manufacturing issue and continues to produce sensors to meet replacement and new orders without significant supply disruptions.

Users can check if their sensors are affected and request free replacements at www.freestylecheck.com.

The company advised users to stop using any confirmed affected sensors immediately and to rely on a blood glucose meter for treatment decisions when sensor readings do not match symptoms.

Other Libre products, readers and apps are not affected, and the correction is also being implemented in other countries where Libre 3 and Libre 3 Plus sensors are sold, Abbott said.

(Reporting by Puyaan Singh in Bengaluru; Editing by Tasim Zahid)