At least 55 000 patients in England will be needing further blood tests after errors made by machines used to diagnose diabetes, a BBC investigation has discovered.
Some patients have been wrongly diagnosed with type 2 diabetes and even prescribed medication, like Metformin, that they don’t need – and there could be more people affected, according to NHS England.
Metformin works by lowering blood sugar levels through improving how the body handles insulin.
NHSE has confirmed 16 hospital trusts use the machines, made by Trinity Biotech, which have produced inaccurate test results.
In a statement, Trinity Biotech said it was working closely with the UK health regulator and has contacted all hospitals who use the machines.
The BBC first reported in September 2024 that 11 000 patients faced re-testing after a machine at Luton and Dunstable Hospital issued incorrect diabetes results.
NHS England now says type 2 diabetes diagnoses rose by 10 000 in 2024, 4% more than expected.
The procedure, known as the haemoglobin A1C test, measures average blood sugar levels which are used to diagnose type 2 diabetes and monitor the condition.
In July this year, the Medicines and Healthcare products Regulatory Agency said it had received reports describing a positive bias delivered by the Trinity Biotech machines, resulting in some patients being incorrectly diagnosed as pre-diabetic or diabetic.
Side effects
NHS trusts are already recalling patients for repeat tests and NHS England says anyone who needs a repeat test will be contacted by their GP or local hospital.
It adds that for those who may have been wrongly diagnosed, the risk is low and they would be given lifestyle advice and offered support programmes first.
Professor Kamila Hawthorne, chair of the Royal College of GPs, said that while errors can and do happen, widespread technology failures like this would be of huge concern for all GPs, “primarily because of the unnecessary distress, inconvenience and anxiety they can cause our patients”.
NHS England said fewer than 10% of its laboratories were affected and all have either replaced the machines or addressed calibration issues.
In response to an inquiry from the BBC, Trinity Biotech said: “The company has worked closely with the MHRA to resolve the issues experienced by some labs using the system.”
It added that it had “issued three Field Safety Notices in 2024 to all UK users, informing them of a potential positive bias issue”.
BBC article – Error leaves 55,000 diabetes patients needing new tests (Open access)
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