The MHRA said manufacturer Lifescan had recalled blood glucose monitors used by around 22,000 people with diabetes after the company found a software glitch that could cause patients to miss extremely high blood glucose levels.
The fault causes OneTouch Verio Pro devices to give falsely low readings and OneTouch Verio IQ models to turn off if blood glucose exceeds the extremely high level of 56.8 mmol/L, though such high levels are rare.
The faulty devices do not alert users to extremely high glucose beyond this level, and so may lead to a delay in diagnosis and treatment of extreme hyperglycaemia, the company said in a statement.
John Wilkinson, the MHRA’s director of medical devices, said: 'Extremely high blood glucose levels in people are rare, but if they do occur the person will require immediate medical attention.'
Simon O’Neill, director of health intelligence at Diabetes UK, said: 'Blood glucose testing is an important part of diabetes management. People using these meters should contact the manufacturer for a replacement but if they are concerned about their blood glucose readings, they should consult with their diabetes care team.'
The affected models are:
- OneTouch Verio Pro (serial numbers that start with RA, RB, RC, RD or RE)
- OneTouch Verio IQ (serial numbers that start with TA or TB)
- OneTouch Verio Pro+ models used only in healthcare settings
Lifescan said it would replace affected models for free.