We learned about this through our ongoing product monitoring, which helps us ensure our products continue to meet customer expectations.
Frequently Asked Questions
What kind of field action is this?
Which products are involved?
A subset of FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors distributed in the United Kingdom are impacted.
What is the problem?
We have identified a subset of FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors that may provide incorrect low glucose readings, which if undetected may pose a serious health risk for people living with diabetes.
How did you find out about this issue?
Are you still shipping FreeStyle Libre 3 and FreeStyle Libre 3 plus sensors?
Yes.
Why do you have confidence that you can continue to ship FreeStyle Libre 3 and FreeStyle Libre 3 plus sensors?
We have identified the root cause and resolved the issue.
What if I have a sensor kit in the original packaging that is affected?
Enter the serial number at www.FreeStyleCheck.com and we will send you a replacement sensor. Afterwards, please discard the affected FreeStyle Libre 3 or Freestyle Libre 3 Plus sensor.
Are FreeStyle Libre 2 Plus sensors affected?
FreeStyle Libre 2 Plus sensors are not affected.
Where can I find the sensor serial number?
If your sensor is still in its package, the serial number can be found on the bottom of the sensor carton packaging and on the sensor applicator label. For sensors in use or already used, the serial number can be found in the FreeStyle Libre 3 reader or app.
Reader:
- From the Settings menu select System Status, then System Info. Multiple Sensor Serial Numbers may be listed. Number (1) is the one you are currently wearing or have most recently worn.
FreeStyle Libre 3 app:
- From the App Main Menu select About. Multiple Sensor Serial Numbers may be listed. The one at the top of the list is the one you are currently wearing or have most recently worn.
Where do I find the sensor serial number in my connected insulin device (automated insulin delivery system (pump)/connected insulin pen)?
If you are using a sensor with a connected insulin delivery device, please refer to the connected insulin delivery device user manual on how to locate the sensor serial number.
Can I still use my unused FreeStyle Libre 3 or Freestyle Libre 3 Plus sensor if it is affected by this issue?
If your sensor is confirmed to be affected, please do not use it. Immediately dispose of any affected sensors in your possession.
What if I am currently wearing a FreeStyle Libre 3 or Freestyle Libre 3 Plus sensor that is affected?
Please immediately stop using the FreeStyle Libre 3 or Freestyle Libre 3 Plus sensor and remove it from your arm. Until your replacement sensor is delivered, use a blood glucose meter, or the built-in meter in your FreeStyle Libre 3 Reader, or a non-affected sensor to make treatment decisions.
What should I do if I’m experiencing low glucose readings, but it does not match how I feel, yet my serial number is not on the affected list?
If glucose readings and alarms (if enabled) do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Get medical attention when appropriate and please contact Abbott’s Customer Service at number: 0800 170 11 77.Mon - Fri (8.00 - 20.00)
Sat, Sun & Bank Holidays (9.00 - 17.00)
What if I have more than one sensor kit that is impacted?
For each sensor that is impacted, please enter your sensor serial number and provide your contact information for shipment of a replacement. Please note, you can only enter one sensor serial number at a time. Each time you enter a sensor serial number, you will need to provide your contact information for shipment of a replacement.
What if my product was not included in this urgent field safety notice?
No action is necessary, and you can continue to use your Libre products.
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