Medical device giant Abbott has initiated a correction for millions of its popular diabetes monitoring sensors following internal testing that revealed potentially dangerous inaccuracies.
For people living with diabetes who rely on these devices to manage their condition minute-by-minute, a false reading is more than just an inconvenience—it poses a significant health hazard.
If a sensor incorrectly tells a user their blood sugar is low when it is actually normal or high, the user might make the wrong treatment choice. According to Abbott, this could lead to "excessive carbohydrate intake" to treat the false low, or it could cause a patient to skip or delay a necessary dose of insulin. These errors in treatment, driven by faulty data, can pose serious health risks, including injury or death.
The scope of the problem is substantial. According to Abbott, the medical device correction involves approximately 3 million sensors distributed in the United States alone. The company estimates that about half of these sensors have likely already been used or have expired.
The human toll associated with this technical glitch has drawn the attention of federal regulators. Globally, Abbott has received reports of 736 severe adverse events potentially associated with this issue. Of those injury reports, 57 came from patients in the United States.
Most concerning are the fatalities. There have been reports of seven deaths globally that are potentially associated with the sensor malfunction. The company said that none of those deaths occurred within the United States.
What Went Wrong
Abbott stated that they have identified and resolved the root cause of the problem. According to their press release, the issue was isolated to a single production line among the several lines that manufacture the Libre 3 and Libre 3 Plus sensors.Instructions for Patients
For the millions of Americans using these devices, immediate action is required to ensure their safety. Abbott and the FDA are urging consumers to verify if their equipment is part of the affected batch.To do this, users need to locate the serial number of their sensor. According to the FDA’s notice, for those currently wearing a sensor, the serial number can be found directly inside the mobile app or on the reader device.
In the FreeStyle Libre 3 app, users should go to the Main Menu, select "About Screen," and look for the serial number under "Last 3 Sensors." For those using the standard Libre app, the path is "Main Menu," then "Profile," then "About."
If a sensor is confirmed to be potentially impacted—either through the website or by speaking with a customer service representative—consumers must stop using it right away.
Medical Guidance
In the meantime, patients are advised not to guess their insulin levels. Patients should use a standard blood glucose meter or the built-in meter in the FreeStyle Libre 3 reader. This is especially critical when the sensor readings do not match one's physical symptoms or expectations, Abbott said.Specific Models Affected
The FDA provided detailed identifiers for the recalled products. The affected products include the FreeStyle Libre 3 Sensor (Model Numbers 72081-01 and 72080-01) and the FreeStyle Libre 3 Plus Sensor (Model Numbers 78768-01 and 78769-01).It is important to note what is not affected. The FreeStyle Libre 3 readers and mobile apps themselves are not impacted by this issue. Furthermore, no other Libre products—such as the FreeStyle Libre 14 day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, or Libre Pro sensors—are affected. Abbott’s other bio-wearable products are also safe to use.
Abbott said they are issuing this medical device correction in other countries where the affected sensors were also distributed.
For those needing assistance, Abbott has set up support channels. Customers can call Abbott’s customer service at 1-833-815-4273. Agents are available seven days a week from 8 a.m. to 8 p.m. ET. Additionally, live chat support is available 24/7 through their support website.