Abbott has launched a voluntary medical device correction for a small quantity of FreeStyle Libre 3 sensors distributed in the US.
FreeStyle Libre 3 system comprises a sensor, reader, and app and this corrective action pertains specifically to the sensors distributed during the first half of May 2024.
The FreeStyle Libre 3 reader and app remain unaffected.
The issue specifically impacts a small subset of FreeStyle Libre 3 sensors from T60001948, T60001966, and T60001969 lot numbers. However, Abbott did not disclose the total number of affected sensors.
During internal testing, it was found that certain sensors from three specific lots may display inaccurately high glucose readings.
If left undetected, the issue could potentially endanger the health of individuals with diabetes. This could lead to incorrect treatment decisions such as unnecessary insulin administration.
Abbott said that if consumers possess FreeStyle Libre 3 sensors from different lots, they do not need to take any action and can continue using their sensors without concern.
Users residing outside of the US or using other variants of FreeStyle Libre products including FreeStyle Libre 14 day, FreeStyle Libre 2, or FreeStyle Libre 2 Plus are not affected by this issue.
Furthermore, the medical technology firm said that consumers who are using an affected sensor should promptly cease its use and dispose of any affected sensors.
The customers can contact the company to arrange a replacement sensor at no cost.
Abbott diabetes care business executive vice president Jared Watkin said: “We’re actively working with the US Food and Drug Administration and distributors, as well as providing information to affected customers, who will receive replacements at no charge as quickly as possible.”
Consumers are advised to perform a fingerstick test using any blood glucose meter if they encounter symptoms that do not align with the sensor glucose reading or if they suspect the reading may be inaccurate.
The built-in blood glucose meter in the FreeStyle Libre 3 reader can also be used at any time to check glucose levels.
In April this year, Abbott issued a safety notification for the FreeStyle Libre family of readers in the US.
Recently, the medical technology company reported a 5.3% decline in Q2 2024 with a net profit of $1.3bn.
