Approximately 3 million glucose sensors across the United States are at the center of a significant health concern, with about half of them potentially expired or already utilized, according to company estimates.
WASHINGTON — A troubling revelation has emerged as faulty glucose sensors, crucial for millions of diabetes patients, have been linked to over 700 severe injuries and seven deaths globally. This information has been jointly disclosed by Abbott Diabetes Care and the U.S. Food and Drug Administration (FDA).
On December 2, the FDA issued an early safety alert following Abbott’s public statement and a direct communication to customers on November 24, highlighting the issue.
The company has described its actions as a “medical device correction,” specifically targeting certain models of its FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring (CGM) sensors.
Given the situation, the FDA published the alert prior to making a decision on a possible formal recall. This move was intended to promptly inform the public while the agency considers further measures.
As of November 14, Abbott has reported 736 serious adverse incidents globally, including 57 cases in the United States. The seven deaths associated with the sensors have all occurred internationally.
Faulty sensors may give dangerously low readings
The affected sensors may produce falsely low glucose readings, which can lead people with diabetes to make treatment decisions that push their blood sugar to unsafe levels. Those responses might include delaying or skipping insulin doses — which raises blood sugar — or consuming excessive carbohydrates.
Incorrect treatment based on inaccurate readings can cause blood sugar to swing out of control and trigger life-threatening complications such as diabetic ketoacidosis, heart attack, stroke, kidney damage, nerve damage or severe infection.
The malfunction involves roughly three million sensors distributed in the U.S., though Abbott estimates that about half are already expired or used.
“Abbott has identified and resolved the cause of the issue, which relates to one production line among several that make Libre 3 and Libre 3 Plus sensors,” the company said in a statement.
Abbott said it does not anticipate major supply disruptions and is continuing to ship replacement and new sensors.
Only specific Libre 3 sensor models affected
The issue is limited to certain FreeStyle Libre 3 Sensors and FreeStyle Libre 3 Plus sensors. The FreeStyle Libre 3 app, reader and all other Abbott Libre systems, including the Libre 14-day, Libre 2, Libre 2 Plus and Libre Pro, are not affected.
Model Numbers: 72081-01, 72080-01
UDI-DI: 00357599818005, 00357599819002
FreeStyle Libre 3 Plus Sensor
Model Numbers: 78768-01, 78769-01
UDI-DI: 00357599844011, 00357599843014
How users can check their sensor
Users can confirm whether their sensor is impacted by locating its serial number in the app, reader or on the product box.
In the FreeStyle Libre 3 app:
On the box or applicator:
What consumers should do
Anyone currently wearing a sensor identified as one of the potentially defective devices should stop using it immediately and safely discard it.
Replacements are available at no cost. Users can check their serial numbers and request replacement products through Abbott’s FreeStyleCheck website by selecting “Confirm Sensor Serial Number” and entering the required information.
The FDA said it will continue to monitor the situation as Abbott distributes corrected sensors and works to resolve the manufacturing issue.
For now, federal regulators are urging CGM users to verify their devices promptly and report any adverse events to the FDA’s MedWatch program.
