A medical device manufacturer is warning that certain models of its glucose monitors may be giving users erroneous readings, a malfunction that it says is responsible for seven deaths and more than 700 injuries worldwide.
The diabetes care division of the manufacturer, Abbott Laboratories, issued an announcement stating that faulty readings from its FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors could lead people with diabetes to mismanage their disease due to incorrect information.
Misleading Readings
Customers who confirm their device is affected “should immediately discontinue use and dispose of it,” according to a company press release. The mishap, it said, has led to an estimated 736 serious injuries and 7 deaths worldwide as of its November 24 announcement.
More than 38 million children and adults, or 11.6% of the total U.S. population, had been diagnosed with diabetes as of 2021, according to the Centers for Disease Control and Prevention. Almost 15% of all adults, and just over 12% of all Black Americans, are diabetic.
Last week, FDA officials warned that falsely low glucose readings could lead people with diabetes to make decisions about diet or insulin that trigger bad outcomes. These could range from eating too many carbohydrates or skipping or delaying insulin doses. Mismanaging blood glucose can result in serious illness or hospitalization.
Almost 9 million U.S. adults who tested as having the disease were unaware or did not report having it. People with diabetes are advised to use a fingerstick test if their symptoms don’t match what their glucose monitor indicates. Individuals should adjust the treatment decisions accordingly and quickly contact a healthcare professional if needed.
Check Serial Numbers
Abbott Diabetes Care has warned that roughly 3 million of the sensors in question could give users false low glucose readings.
Approximately half of those devices are estimated to have expired or been used, Abbott said. The company will replace any potentially affected sensors free of charge.
Consumers wearing a FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensor can find the serial number in the app or reader. The serial number could also be on the label on the bottom of the sensor applicator or carton.
The affected model numbers are the FreeStyle Libre 3 sensors with model numbers 72080-01. The FreeStyle Libre 3 Plus sensors have model numbers 78768-01 and 78769-01 and unique device identifiers 00357599844011 and 00357599843014.
Website Available
For sensors connected to an insulin delivery device, check the connected insulin delivery device user manual on how to locate the sensor serial number.
Consumers can also confirm if current or unused sensors are affected by visiting Abbott’s website and selecting “Confirm Your Sensor Serial Number.” Be sure to select “United States,” or the country where you purchased the device, from the dropdown menu that’s at the very top right of the site.
The company’s customer service is also available at 1-833-815-4273, available seven days a week from 8 a.m. to 8 p.m. EDT.
