Diabetes Glucose Monitors Recalled After 7 Deaths And Than 700 Injuries

Diabetes Glucose Monitors Recalled After 7 Deaths And Than 700 Injuries
NEED TO KNOW
- Abbott Diabetes Care has issued a recall and is warning patients to stop using certain glucose monitors following the deaths of seven people
- Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus devices were recalled after Abbott found they had malfunctioning sensors during internal testing
- Anyone with an impacted device should stop using it immediately
Abbott Diabetes Care is warning patients to stop using certain glucose monitors that have been recalled following the deaths of seven people.
On Tuesday, Dec. 2, the U.S. Food and Drug Administration (FDA) announced that Abbott has issued a warning after its internal testing found that some sensors in its FreeStyle Libre 3 and FreeStyle Libre 3 Plus devices had malfunctioning sensors and may be linked to hundreds of adverse events.
“Abbott initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the U.S. after internal testing determined that some of these sensors may provide incorrect low glucose readings,” the company told PEOPLE in a statement.
Abbott added that it had “contacted customers to make them aware and provide support,” and that no other Libre products beyond those two models are impacted by the recall.
Users can visit www.FreeStyleCheck.com to determine if their sensor is affected and request a replacement, according to the company.
Anyone with an impacted device should stop using it, Abbott and the FDA said. According to the company, patients impacted should use a blood glucose meter or the built-in meter on a FreeStyle Libre 3 Reader to make treatment decisions when sensor readings don’t match symptoms or expectations.
DELS DELS / BELGA MAG/Belga / AFP of Getty
In apress releasethe company said it had received reports of 736 “severe adverse events” that may be linked to the monitors, 57 of which were in the U.S.
Seven deaths were also reported, all of which were outside the U.S. The FDA called the issue “potentially high-risk.”
“This action involves approximately 3 million Libre 3 and Libre 3 Plus sensors in the U.S. from (one) production line, about half of which are estimated to have expired or been used,” Abbott said.
The FDA and Abbott said that anyone using a a Libre 3 or Libre 3 Plus sensor should check its model number and unique device identifier to see if it is one of the impacted devices.
Users can follow the instructions on the FDA’s website to find their serial number, or visit www.FreeStyleCheck.com to confirm whether their sensor is affected.
The model numbers for the affected FreeStyle Libre 3 sensors are 72081-01 and 72080-01, and the unique device identifiers are 00357599818005 and 00357599819002. For the affected FreeStyle Libre 3 sensors, the model numbers are 78768-01 and 78769-01; the unique device identifiers are 00357599844011 and 00357599843014.
Abbott said it will replace any potentially affected sensors at no charge.
Jamie Kelter Davis/Bloomberg via Getty
According to the Mayo Clinicpeople with diabetes use blood glucose meters to measure and display the amount of glucose, or sugar, in their blood. Exercise, food, medications, stress and other factors affect the blood glucose level, and the use of blood glucose meters can help patients manage their condition.
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“If undetected, incorrect low glucose readings over an extended period may lead to incorrect treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses,” the company said. “These decisions may pose serious health risks, including potential injury or death, or other less serious complications.”
According to Abbott, the company has since identified the cause of the sensor issues and fixed it.
“The company continues to produce Libre 3 and Libre 3 Plus sensors to fulfill replacement and new orders and does not expect significant supply disruptions,” Abbott added to PEOPLE.
Disclaimer: This news article has been republished exactly as it appeared on its original source, without any modification.
We do not take any responsibility for its content, which remains solely the responsibility of the original publisher.
Disclaimer: This news article has been republished exactly as it appeared on its original source, without any modification.
We do not take any responsibility for its content, which remains solely the responsibility of the original publisher.
Author: uaetodaynews
Published on: 2025-12-05 01:04:00
Source: uaetodaynews.com




