FDA Warns Public About Defective Glucose Monitors

The U.S. Food and Drug Administration is warning people with certain glucose monitor sensors to stop using them, after manufacturer Abbott Diabetes Care discovered that they provide incorrect low glucose readings. The devices have been linked to seven deaths and more than 700 serious injuries globally.

Glucose monitor sensors sit just under the skin and give real-time measurements of the amount of sugar (glucose) in a person’s blood. They are commonly used by people with diabetes, a chronic disease that affects nearly 1 in 3 older adults.

In a Dec. 2 alert, the FDA said certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may provide incorrect readings. Over time, incorrect low glucose readings “may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses.” And these decisions, the FDA said, “may pose serious health risks, including potential injury or death, or other less serious complications.”

USDA.gov

Affected Products

FreeStyle Libre 3 sensor

• Model numbers: 72081-01, 72080-01
• Unique device identifiers (UDI-DI): 00357599818005, 00357599819002

FreeStyle Libre 3 Plus sensor

• Model numbers: 78768-01, 78769-01
• Unique device identifiers (UDI-DI): 00357599844011, 00357599843014

See the full details in the FDA’s alert.

Approximately 3 million sensors in the U.S. may be affected, all from a single production line, according to the manufacturer. The FreeStyle Libre 3 readers and mobile apps are not affected. Consumers should visit www.FreeStyleCheck.com or call 1-833-815-4273 to confirm whether their sensor is affected, using the sensor’s serial number, which can be found in the app or reader. (See the FDA’s alert for a visual guide on where to find the serial numbers in the app.) The serial number can also be found on the label on the bottom of the sensor applicator or carton.

Anyone with an affected sensor should stop using it right away and dispose of it, health officials say.

Abbott says it has received reports of 736 severe adverse events globally (57 of which were in the U.S.) and seven deaths (none of which were in the U.S.) potentially associated with this issue. The company says it has resolved the manufacturing issue related to the devices.