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Medical Devices Health Regulator Issues Warning to Diabetics about Faulty Blood Glucose Test Strips

The Medicines and Healthcare products Regulatory Agency (MHRA) today asked people with diabetes to check if they have certain lot numbers of a specific type of blood glucose test strip, because 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 (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).

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.>

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.

Abbott Diabetes Care, the manufacturer of the tests strips, has already written to healthcare professionals and customers about this. They are advising that people should contact their customer service team on 0800 072 1020 for free replacement 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. 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.

 

Source: The MHRA's Medical Device Alert can be viewed here

 

 

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