Faulty glucose monitors linked to 7 deaths and more than 700 injuries,
FDA warns
[December 05, 2025]
By JONEL ALECCIA
The U.S. Food and Drug Administration is warning people to stop using
certain types of glucose monitor sensors after the company that makes
them, Abbott Diabetes Care, said the devices were linked to seven deaths
and more than 700 injuries.
Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may provide
incorrect low glucose readings, FDA officials said this week. Such
readings over an extended period may lead people with diabetes to make
bad treatment decisions, such as consuming too many carbohydrates or
skipping or delaying doses of insulin.
“These decisions may pose serious health risks, including potential
injury or death," the FDA said in the alert.
The sensors are devices that measure glucose levels in fluid just
beneath the skin to provide real-time measurements of sugar in the
blood. Information from the sensor is sent wirelessly to a device or
phone.
The warning affects about three million sensors in the U.S. from a
single production line, Abbott officials said in a statement. About half
those devices have expired or been used, the company added. As of Nov.
14, the company reported seven deaths worldwide and 736 serious adverse
events. No deaths occurred in the U.S., where 57 injuries were reported.
Abbott has notified all customers of the problem. The company said it
has identified and resolved the issue in the affected production lot.
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The Food and Drug Administration seal is seen at the Hubert Humphrey
Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose
Luis Magana, File)
 The FDA said people should stop
using affected sensors and discard them.
The problem involved FreeStyle Libre 3 sensors with model numbers
72080-01 with unique device identifiers 00357599818005 and
00357599819002. It also involved FreeStyle Libre 3 Plus sensors with
model numbers 78768-01 and 78769-01 and unique device identifiers
00357599844011 and 00357599843014.
People can visit www.FreeStyleCheck.com to check if their sensors
are potentially affected and request a replacement, the company
said. No other FreeStyle Libre products are affected.
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