Warning about faulty Freestyle Lite Blood Glucose Test Strips

Warning about faulty Freestyle Lite Blood Glucose Test Strips

06.12.13

The Medicines and Healthcare products Regulatory Agency (MHRA) has asked people with diabetes to check if they have certain lot numbers of Freestyle Lite of blood glucose test strips. A manufacturing fault in some of the strips may mean that people could receive inappropriate treatment.

Three lots of Freestyle Lite Blood Glucose Test Strips are affected by the fault:
lot numbers 1284962, 1366626, 1372611
The issue only occurs when they are used with the following meters:
FreeStyle® Blood Glucose Meters (manufactured by Abbott)
FreeStyle Mini® Blood Glucose Meters (manufactured by Abbott) FreeStyle Navigator® (manufactured by Abbott)
FreeStyle® meter built into the Omnipod® Insulin Management System (manufactured by Insulet Corporation).

Around 15,000 of these meters in the UK use the Freestyle Lite Blood Glucose Test Strips. The fault means that some of the test strips may give inaccurate readings and therefore people could potentially receive inappropriate treatment.  People should continue to test their blood glucose but should be aware that they could give a misleading low reading.

When the affected Freestyle Lite Blood Glucose Test Strips are used with newer meter brands (FreeStyle Lite® Blood Glucose Meters, FreeStyle Freedom Lite® Blood Glucose Meters, FreeStyle Insulinx® Blood Glucose Meters and FreeStyle Navigator® II), this issue does not occur.

The manufacturing fault has now been resolved and there is currently no evidence that any patients in the UK have been adversely affected by any faulty test strips.

If people have the faulty test strips they can telephone the manufacturer on 0800 072 1020 who will provide free replacements. If they have questions, they can contact their diabetes nurse, pharmacist or GP who can give them advice about what alternative test strips they can use.


Note – the MHRA’s Medical Device Alert can be found at:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON348297