Camilla Jessen
Massive diabetes-device recall issued nationwide.
The pharmaceutical company Abbott has issued a sweeping “medical device correction” affecting around three million of its glucose sensors in the United States.
The company warns that inaccurate low readings from the faulty sensors have led to over 700 severe medical emergencies and even 7 deaths.
Sensors providing false low readings
According to Abbott’s recall announcement, the issue affects FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors used by people with type 1, type 2 and gestational diabetes.
The malfunction can cause the device to display false low glucose levels, potentially leading users to skip or delay insulin, which can trigger life-threatening complications.
The company confirmed 736 severe adverse events linked to the faulty sensors, including 57 in the U.S.
While no U.S. deaths have been reported, Abbott said there have been seven deaths globally associated with the affected devices.
How to check your device
Abbott has created a verification site for users, which you can find on www.FreeStyleCheck.com
Enter your sensor’s serial number to determine whether it falls within the recalled batches.
If your device is affected, Abbott will replace it free of charge. Users can request a replacement by contacting Abbott’s customer service.
The company emphasized that no other Libre sensors, readers or mobile apps are part of this recall.
What users should do
If you have recently brought a FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensor recently, get it checked out immediately.
If it is affected by this recall, stop using it and order a replacement. Monitor your glucose levels with backup methods until you receive a new sensor.
Seek medical care if you experience symptoms of hypoglycemia or hyperglycemia
Abbott says it is working with regulators to address the malfunction and ensure replacements are delivered quickly.
Sources: Abbott press release
