Incorrect diagnoses for type 2 diabetes due to machine error mean thousands face additional blood tests
Patients incorrectly diagnosed as having pre-diabetes or type 2 diabetes following fault in blood glucose results.
Up to 55,000 people face having to have the blood glucose levels re-tested following a fault found in routine machine analysis.
The Medicines and Healthcare products Regulatory Agency (MHRA) has reported “a positive bias in HbA1c results delivered by the Trinity Biotech Premier Hb9210 HbA1c analyser, which has resulted in patients being incorrectly diagnosed” with pre-diabetes or type 2 diabetes.
The MHRA said they were working closely with the manufacturer, Trinity Biotech, to resolve the issue.
In addition, Trinity Biotech, has committed to “provide further clarity regarding the frequency of preventative maintenance required to ensure the consistent performance of the analyser”.
Healthcare professionals are advised to consider whether recalling and retesting is required for any patients newly diagnosed as [having type 2 diabetes] between April 2024 to the present”.
In addition, affected patients are advised to “seek medical attention immediately if adversely affected following any changes to medication, such as hypoglycaemia (shaking/trembling, sweating, confusion, loss of consciousness) or hyperglycaemia (excessive thirst, blurred vision, recurrent infections)”.
NHS England confirmed that 16 hospital trusts use the machines, made by Trinity Biotech, which have produced the inaccurate test results.
All hospitals which use the machines have been contacted.
Bedfordshire Hospitals NHS Foundation Trust, one of the affected organisations, said: “We are currently contacting a number of patients in the Luton, South Bedfordshire and Hertfordshire areas to ask them to attend for a repeat blood test. This is because some patients may have received an HbA1c blood test result that was higher than actual.
“You may receive a call from the hospital in the coming weeks asking you to come and have another blood sample taken for re-testing. Please be assured that we will contact you if your result might have been affected. We are asking residents to please avoid calling the hospital or your GP to ask whether you need to be re-tested because we need to focus our effort on arranging the retests with those patients who need them.
“We sincerely apologise for any emotional distress and inconvenience that has been caused by this issue. We are undertaking a detailed review to find out what went wrong and identify any learning.”
NHS England reported type 2 diabetes diagnoses were up by 10,000 in 2024, a rise that was 4% more than expected.
The HbA1c (haemoglobin A1C) test measures average blood glucose levels which are used to diagnose type 2 diabetes and monitor the condition.
According to the MHRA, issues with the tests on these machines was first reported in April 2024.
Read more about type 2 diabetes
Read the DRWF diabetes information leaflet Managing diabetes when you are ill
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