Misuse may cause battery overheating and incorrect readings
The FDA has issued a safety notification regarding the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems. The notification warns users of the potential for inaccurate glucose readings if the devices are not used properly, stored correctly, or if the sensor is not replaced as directed.
The US Food and Drug Administration (FDA) has issued a safety alert after Abbott issued a notification for its FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems. The notification relates to the proper storage, charging, and use of the device. This article discusses the details of the safety alert and its implications for users of the Freestyle Libre family readers.
Background
The Freestyle Libre family readers are glucose monitoring devices that use a sensor to measure glucose levels in people with diabetes. The device is designed to be worn on the skin and communicates with a reader or a smartphone app to display glucose readings. The device is manufactured by Abbott Diabetes Care, a division of Abbott Laboratories.
The safety alert
The safety alert issued by the FDA relates to the proper storage, charging, and use of the Freestyle Libre family readers. According to the notification issued by Abbott, if not properly stored, charged, or used with the Abbott-provided yellow USB cable and power adapter, a potential exists for battery swelling and, in rare cases, extreme overheating, which may pose a fire hazard.
The device should be stored between 32°F and 113°F (0°C and 45°C) and should not be exposed to extreme temperatures. If the device is not properly stored, charged, or used, it may result in inaccurate glucose readings.
Using charging methods other than the Abbott yellow USB cable and power adapter may result in the aforementioned damage to the device and may also cause inaccurate glucose readings. Users are advised to clean the device regularly and to replace the sensor as directed.
Implications for users
The safety alert issued by the FDA and the notification issued by Abbott have important implications for users of the Freestyle Libre family readers. Users should take the following steps to ensure the proper storage, charging, and use of the device:
- Store the device between 32°F and 113°F (0°C and 45°C) and avoid exposing it to extreme temperatures.
- Charge the device using the provided USB cable and power adapter.
- Clean the device regularly and replace the sensor as directed.
Users should also be aware of the potential consequences of improper storage, charging, and use of the device. If the device is not properly stored, charged, or used, it may result in inaccurate glucose readings, which can have serious health consequences for people with diabetes. Inaccurate glucose readings can lead to incorrect insulin dosing and can cause hypoglycemia or hyperglycemia.
Conclusion
The safety alert issued by the FDA and the notification issued by Abbott highlight the importance of proper storage, charging, and use of the Freestyle Libre family readers. Users should take the necessary precautions to ensure the device is properly stored, charged, and used to avoid inaccurate glucose readings and potential health consequences. People with diabetes should consult with their healthcare providers if they have any concerns about the use of the Freestyle Libre family readers.
Links
Read more about the safety notification here.