Urgent Recall: Abbott Diabetes Care Warns of Faulty Glucose Monitors Linked to Adverse Events and Deaths
Patients using certain glucose monitors made by Abbott Diabetes Care are being warned to stop using them immediately due to a potential link to hundreds of adverse events and several deaths. According to the Food and Drug Administration (FDA), internal testing by Abbott found that some sensors in FreeStyle Libre 3 and FreeStyle Libre 3 Plus devices may provide incorrect low glucose readings.
The company has reported 736 adverse events potentially linked to the issue, with 57 of these events occurring in the United States. Unfortunately, seven deaths, none of which were in the U.S., have been potentially associated with the sensor error. The FDA has referred to the error as a “potentially high-risk issue” due to the critical nature of glucose readings for people with diabetes.
Understanding the Risks and Implications
For individuals with diabetes, accurate glucose readings are crucial for managing their care. Incorrect low readings can lead to excessive carbohydrate intake or skipped or delayed insulin doses, posing serious health risks, including potential injury or death. The sensor issue has been identified as related to one production line among several that manufacture the Libre 3 and Libre 3 Plus sensors, with approximately three million devices affected.
It’s essential for users to check their device’s model number and unique device identifiers to determine if it is one of the affected devices. The model numbers for the affected FreeStyle Libre 3 sensors are 72081-01 and 72080-01, with unique device identifiers 00357599818005 and 00357599819002. For the FreeStyle Libre 3 Plus sensors, the model numbers are 78768-01 and 78769-01, with unique device identifiers 00357599844011 and 00357599843014. A full list of affected lots can be found on the FDA’s website.
Recommended Actions and Precautions
Abbott and the FDA advise anyone with an impacted device to stop using it immediately. Patients can request free replacement devices on www.FreeStyleCheck.com. In the meantime, patients should use a blood glucose meter or the built-in meter on a FreeStyle Libre 3 Reader to make treatment decisions when sensor readings don’t match symptoms or expectations.
It’s reassuring to note that FreeStyle Libre 3 readers and mobile apps have not been impacted, and no other Libre-brand sensors are affected by the sensor issue. Abbott has identified and resolved the cause of the sensor issue, and no supply disruptions are expected. For the latest information and updates, patients can visit the FDA’s website or consult with their healthcare provider.
Edited by Stephen Smith, this recall highlights the importance of vigilance and prompt action in ensuring patient safety. For more information on this recall and other health-related news, visit Here
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