Regulator issues warning over small number of TRUEyou home-use blood glucose test strips
TRUEyou blood glucose test strips - certain lots of test strips may give incorrect low blood glucose results that could lead to undetected hyperglycaemia.
The Medicines and Healthcare products Regulatory Agency (MHRA) is asking people currently using affected batches of TRUEyou blood glucose test strips to stop using them and return them to the manufacturers.
Due to an issue with the packaging process there is a risk that affected batches may give incorrect low blood glucose results which could lead to undetected hyperglycaemia.
John Wilkinson, MHRA’s Director of Medical Devices said:
This issue relates to a small number of home-use blood glucose test strips, however it is still important that people continue to monitor their blood glucose levels effectively.
The number of affected products in circulation is thought to be low, but anyone using the TRUEyou test strips is advised to discontinue using products with affected lot numbers and return these to the manufacturer for replacement.
If patients are concerned about their blood glucose readings when using this meter we advise them to contact their healthcare professional and we continue to encourage people to report any issues involving medical devices to MHRA via our Yellow Card Scheme.
See the Medical Device Alert for more information.
Report any problems with medical devices via the Yellow Card Scheme.
MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. 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). MHRA is an executive agency of the Department of Health.
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Published: 30 June 2016