Urgent Field Safety Notice: FreeStlye Libre 2 Sensors

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Abbott is initiating a voluntary recall of certain FreeStyle Libre® 2 sensors and are implementing additional measures to address this issue.

Affected lot number: KTP005061

Please note that no other Abbott diabetes products are affected.

Problem/issue:

  • certain sensors from the above lot may provide erroneously high glucose readings
  • the sensor glucose reading may be high and out of patients’ target range, while the actual glucose levels may be below or within target range.

Potential harms of undetected erroneously high glucose readings:

  • can present a potential health risk for users with diabetes
  • can lead to incorrect treatment decisions, such as taking insulin when not required.

Actions required by users:

  • determine if current sensor in use, or any unused sensors, are affected by visiting www.FreeStyleConfirm.com and entering sensor serial numbers
  • if currently using the FreeStyle Libre® 2 system and wearing an affected sensor, immediately discontinue use
  • if symptoms are present that do not match the sensor glucose reading, or there is suspicion the reading is inaccurate, check the reading by conducting a fingerstick test using a blood glucose meter
  • replacement sensors are to be supplied by Abbott for any users with affected sensors – no prescriptions for replacement sensors are to be issued for any users with affected sensors
  • while waiting for replacement sensor(s), users can continue to use sensors that are not affected, and can use an existing blood glucose meter to check glucose
  • Abbott will send users a mailing kit to return any affected sensor(s) to them.

Actions for healthcare professionals/providers:

  • please communicate this issue to patients who are users of FreeStyle Libre® 2 sensors, or to those you know have been supplied sensors from the affected lot
  • pharmacies, dispensing doctors, or healthcare providers who supply patients with sensors/have an inventory of sensors should check their inventory to identify affected sensors
    • as above, it can be determined if sensors are affected by visiting www.FreeStyleConfirm.com and entering sensor serial numbers
    • affected sensors should not be dispensed/supplied to patients
    • Abbott will arrange free of charge replacement and collection of any affected sensors.

Links:

Abbott have notified the Medicines and Healthcare Products Regulatory Agency (MHRA) of this Field Safety Notice (FSN) and it can be found on their website Medicines and Healthcare products Regulatory Agency (filecamp.com) (MHRA reference 5044080)

Contact:

  • if you have any further questions, the Abbott Customer Service team can be contacted on 0800 032 1016. Patients can contact Abbott Customer Careline on 0800 170 1177.