1,500 patients may need retest over potential results error

Hundreds of patients are being contacted over potentially incorrect results at a second NHS trust, as more laboratories report concerns over diabetes tests, HSJ understands. 

Bedfordshire Hospitals Foundation Trust was the first to report an issue over blood tests earlier this year, saying up to 11,000 patients may have received the wrong results – including a misdiagnosis of diabetes. 

But the Medicines and Healthcare Products Regulatory Agency has confirmed to HSJ that other laboratories across the country have reported concerns over the same device, which measure glucose control. 

The Hb1AC blood test is used to diagnose diabetes and prediabetes, as well as manage existing conditions. 

A spokeswoman said clinical care was unlikely to have been affected, but doctors were reviewing individual circumstances and patients would be contacted if they needed a new test. 

Several field safety notices have now been published for the Premier Hb9210 HbA1c analyser device, manufactured by Trinity Biotech.

Dr Janine Jolly from MHRA said the regulator was working closely with the manufacturer to ensure corrective actions were being put in place. 

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Source: HSJ, 27 November 2024