Safety notice - FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors

Continuous glucose monitoring devices – FreeStyle Libre 3 sensor and FreeStyle Libre 3 Plus sensor – Abbott Diabetes Care Ltd

The Pharmacy and Medicines Division (DPM) has been informed by Abbott Diabetes Care Inc. of the recall of several batches of FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors, used either with the FreeStyle Libre 3 app (on smartphones) or with the mylife CamAPS FX app included in the mylife YpsoPump insulin pump system. No other FreeStyle sensor references are affected.

According to the manufacturer's information, patients have been directly informed of this action via the FreeStyle Libre 3 and mylife CamAPS FX apps or by email.

This recall follows several medical device vigilance reports due to sensors providing incorrect measurements of abnormally low glucose levels. These incorrect measurements can lead to inappropriate therapeutic decisions in people with diabetes, which can result in serious health risks.

Lots concernés

What to do

According to information from the manufacturer, patients using FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors have been advised to visit www.FreeStyleCheck.com to check whether the sensors they have are affected by the recall. The serial number can be found on the box or in the app.

If applicable, patients should not use a sensor affected by the defect and are advised to discard it. They should use another method of blood glucose monitoring until they can obtain another sensor that is not affected by the defect.

Patients can request a free replacement for the affected sensors from the manufacturer.

As a reminder, if the sensor readings do not match the symptoms experienced or the expected level, patients are advised to check their glucose levels using a capillary blood glucose meter.

If you have any questions, please contact your medical device market surveillance authority, the Pharmacy and Medicines Division of the Health Directorate, at meddevices.vigilance@ms.etat.lu