|Date:||14 August 2013|
|Subject:||MHRA issues warning to diabetics about faulty blood glucose test strips|
|Contact:||Press Office 020 3080 7651
Out-of-hours 07770 446 189
The MHRA today asked people with diabetes not to use certain lots of a specific type of blood glucose test strip because a fault in some of the strips may mean that people could overestimate the amount of insulin they need to take.
The test strips affected by the manufacturing fault are called the GlucoMen LX Sensor blood glucose test strips. They are used with the GlucoMen LX and GlucoMen LX PLUS blood glucose meter and they are manufactured by Menarini in Italy.
Just over 1.7 million test strips in the affected lots were sold to pharmacies in the UK between October and November 2012. The fault means that some of the test strips may give inaccurate readings and therefore people could potentially overestimate the amount of insulin they need.
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.
People can check if they have the affected test strips at home by looking for the lot numbers below on the tubs of test strips:
- Lot 3212219249, expiry date 31 August 2014
- Lot 3212214249, expiry date 31 August 2014
While they haven’t been sold in the UK since November 2012, it’s possible that some of the unused faulty blood test strips may still remain in people’s homes. People can get alternative test strips. Other lots of these test strips are not affected and they can continue to be used.
John Wilkinson, the MHRA’s Director of Medical Devices, said:
“People who have GlucoMen LX Sensor blood glucose test strips from these specific lots at home should not use them. The manufacturing fault in these test strips could give a misleading reading that may result in people overestimating the amount of insulin they need to take.
“This fault has been resolved and the two affected lots of faulty test strips have not been sold in the UK since November. 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’s Menarini on 0800 243667 who will provide free replacements. If they have questions, they can contact their GP, diabetes clinic or another healthcare professional who can give them advice about what alternative test strips they can use.”
Notes to Editor
- Medical Device Alert: GlucoMen LX Sensor blood glucose test strips manufactured by Menarini (MDA/2013/064)
- Diabetes UK’s Careline is available Monday-Friday, 9am-5pm on 0845 120 2960 for all general diabetes related enquiries.
- The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Underpinning all our work lies robust and fact-based judgements to ensure that the benefits justify any risks. The MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health.