NHS says at least 55,000 people will need further blood tests after errors were discovered at one in ten NHS labs in England as national clinical director Dr Clare Hambling called it “worrying”
Thousands of people may have been mistakenly diagnosed with Type 2 diabetes due to an error with testing machines.
At least 55,000 people will need further blood tests after errors were discovered at one in ten NHS labs in England. Many of those misdiagnosed will have been prescribed medicines they did not need. NHS diabetes national clinical director Dr Clare Hambling said: “Being potentially misdiagnosed with any long-term condition, such as type 2 diabetes, is understandably worrying, however the clinical risk of harm to patients following this issue is low.”
NHS England confirmed that 16 hospital trusts use the machines, made by Trinity Biotech, which have produced inaccurate test results.
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One patient told of her fury after enduring side effects of diabetes drugs which she should never have been taking.
Vicky Davies, 36, from Kingston upon Hull, was told she had type 2 diabetes in October 2024 and was put on the strongest dose of diabetes drug Metformin for six months before the error was discovered.
She told BBC News : “It’s had a huge effect on my life. Since the diagnosis I have suffered with stress and had to take time off work to attend appointments. I’ve complained to my GP, but I didn’t really get an apology. I’m just so angry.”
The BBC investigated the issue after first reporting in September 2024 that 11,000 patients faced re-testing after a machine at Luton and Dunstable Hospital issued incorrect diabetes results.
The procedure, known as the haemoglobin A1C test, measures average blood sugar levels which are used to diagnose diabetes and monitor the condition. The Medicines and Healthcare products Regulatory Agency (MHRA) now says issues with tests on the machines were first reported in April 2024.
Trinity Biotech said: “The company has worked closely with the MHRA to resolve the issues experienced by some UK labs using the system.”
The statement also said the company had “issued three Field Safety Notices in 2024 to all UK users, informing them of a potential positive bias issue”. It added that these notices included “reiteration of details of the actions to be taken to ensure optimum operation of the system, with an emphasis on the importance of operating the system per the manufacturer’s instructions”.
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Patients have told of the stress and worry of getting a diabetes diagnosis which turned out to be wrong.
Diabetes drug Metformin works by lowering blood sugar levels by improving the way the body handles insulin. However side effects can sometimes include shaking, sweating, confusion, loss of consciousness, excessive thirst, blurred vision and recurrent infections.
NHS England’s Dr Clare Hambling added: “All laboratories have either replaced the machines or addressed calibration issues following MHRA advice in July – and anyone requiring a repeat test will be contacted by their GP or local hospital.”