Nov 24 (Reuters) -
Abbott Laboratories ( ABT ) 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 which occurred in the United States.
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.