Medical Device Alert: FreeStyle Lite home-use blood glucose test strips manufactured by Abbott Diabetes Care
09 December 2013
The Medicines and Healthcare products Regulatory Agency (MHRA) has 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 are affected by the manufacturing fault. The affected lot numbers and expiry dates are as follows:
- 1284962 – 06/2014
- 1366626 – 12/2014
- 1372611 – 02/2015
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.
If you have affected product, we recommend you take the following steps:
- For people with diabetes. Do not continue to use the affected test strips lots. Please immediately dispose of the lots. If the lot numbers of the test strips you currently have are NOT mentioned above, you may continue to use them. There are no other Abbott Diabetes Care products affected by this issue.
- For healthcare professionals or pharmacists. Do not continue to supply or distribute the affected test strips lots. Please immediately dispose of the lots in accordance with your local disposal regulations. If the lot numbers of the test strips you currently have are NOT mentioned above, you may continue to use or distribute them. There are no other Abbott Diabetes Care products affected by this issue.
- Healthcare professionals should ensure that users who dispose of test strips from the affected lots can continue to monitor their blood glucose.
- Call Abbott Diabetes Care Customer Service immediately on 0800 032 1016 for a replacement of the affected test strips. When you call, Abbott will send you unaffected FreeStyle Lite Blood Glucose Test Strips at no charge.