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Faulty glucose test strips revealed

Faulty blood glucose test strips have been revealed by the Medicines and Healthcare products Regulatory Agency (MHRA). 

The MHRA has warned people with diabetes to check if they have a specific type of blood glucose test strip. 

A manufacturing fault means that some of the test strips may give inaccurately low readings, which could lead to inappropriate treatment. 

Three lots of Freestyle Lite Blood Glucose Test Strips (lot numbers 1284962, 1366626, 1372611) are affected by the manufacturing fault. The issue only occurs when they are used with the following diabetes meters that are used for home monitoring of Type 1 and Type 2 diabetes:

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).

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.

John Wilkinson, the MHRA's director of medical devices, said: “People who have Freestyle Lite Blood Glucose Test Strips at home should continue to test their blood glucose sugar but should be mindful that they could give a misleading low reading.

“While three lots of the test strips have been affected by the manufacturing fault this problem has been resolved and there is no evidence that any patients in the UK have been adversely affected by the faulty test strips.” 

If people have the faulty test strips at home they can telephone the manufacturer on 0800 072 1020 who will provide free replacements.