Incorrect readings risk for users of continuous glucose monitor sensors

Abbott, manufacturers of the FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors, issue guidance to users.

Abbott has announced an urgent safety notice following reports that FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors could provide incorrect low glucose readings. 

Abbott stressed this issue does not apply to any other Libre sensors, apps or readers available in the UK. 

A statement from Abbott said: “Ensuring consumer safety and product quality are our highest priorities, which is why we have already begun notifying consumers about this situation through a variety of communications, including in-app notifications, emails and through healthcare providers.”

Abbott offered the following advice to customers who may be affected by this issue:

·    People using FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors should visit here or call Abbott Customer Service on 0800 170 11 77 to confirm if their sensors are impacted. If their sensor is impacted, they will be instructed to provide their contact information so a replacement product can be sent to them at no cost. 

·    If someone is currently wearing or has a FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensor that has been confirmed as affected here or by Abbott Customer Service, they should immediately discontinue use and dispose of the affected sensors. 

·    People can continue to use FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors that are not impacted. 

·    Important reminder: Individuals should use a blood glucose meter such as the built-in meter in the FreeStyle Libre 3 Reader to make treatment decisions when sensor readings do not match symptoms or expectations. 

Continuous glucose monitors and hybrid closed loop systems are technology that can help people with diabetes manage their blood glucose (sugar) levels.

The Abbott FreeStyle Libre 3 system is a continuous glucose monitor that gives glucose readings in real-time via an app on a compatible smartphone. It is available on the NHS for some people.

Abbott confirmed that the Medicines and Healthcare products Regulatory Agency (MHRA) has been notified about this issue.