Abbott Laboratories have issued with a field safety notice warning of a fault affecting certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose sensors

Abbott Laboratories, the manufacturer has discovered that some sensors could give inaccurate low glucose readings, which could lead to inappropriate treatment decisions and potentially serious harm among people with diabetes. The issue is limited to the FreeStyle Libre 3 and Libre 3 Plus sensors and Abbott stressed this issue does not apply to any other Libre sensors, apps or readers available in the UK.

Abbott said: ‘If undetected, incorrect low glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses. These decisions may pose serious health risks, including potential injury or death, or other less serious complications.’

You can tell a FreeStyle Libre sensor is faulty if your reader displays an error message, the sensor has fallen off or become dislodged, or your glucose readings are inconsistent with your symptoms. To confirm, perform a fingerstick blood glucose test with a meter and compare the results. If the sensor consistently fails or readings don’t match how you feel, it’s likely faulty, and you should replace it and contact customer service for further assistance.

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

• People using FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors should 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.
  Contact details of Abbott Customer Service at 0800 170 11 77, Mon – Fri (8.00 – 20.00) Sat, Sun & Bank Holidays (9.00 – 17.00)
• If someone is currently wearing or has a FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensor that has been confirmed as affected 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: People 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.

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

In the US the following statement has been made
Certain glucose monitors from Abbott Diabetes Care are providing users with incorrect glucose readings, an error that has been linked with the deaths of at least seven people and more than 700 serious injuries worldwide, according to an alert from the US Food and Drug Administration.