1,500 patients may need retest over potential results error

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. 

One affected trust is Maidstone and Tunbridge Wells FT, which said around 1,500 patients had been identified for a retest following a technical issue affecting results in July.

A spokesman said the problem was escalated to the supplier as soon as possible, and that affected patients would be contacted by GPs. 

At least four other laboratories run by NHS trusts have reported concerns but found retests would not be necessary.

Independent provider HCA UK Laboratories said it was investigating a concern that HbA1c blood test results in August and until 19 September may have been slightly higher than they should have been due to the issue. The analysers were now not used. 

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. HSJ asked how many would be affected but received no response.

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. 

Laboratories

NHSE has shared a list of seven laboratories which have lodged a complaint over Hb1AC performance, which is understood to be the latest list from MHRA. 

These are:

• Maidstone Hospital (Maidstone and Tunbridge Wells Trust)
• Hemel Hempstead Hospital (West Hertfordshire Teaching Hospitals Trust)
• James Cook University Hospital (South Tees Hospitals FT)
• Hull Royal Infirmary (York and Scarborough Teaching Hospitals FT)
• HCA Laboratories (independent provider)
• Norfolk and Norwich Hospital (Norfolk and Norwich University Hospitals FT)
• Luton and Dunstable Hospital (Bedfordshire Hospitals FT)

Maidstone and Tunbridge Wells Trust said the issue only affected patients in July, and more regular testing and auditing would monitor accuracy of the device going forwards.

South Tees Hospitals FT and York and Scarborough Teaching Hospitals FT said potential differences in results were detected, but quality control measures meant no retests have been needed.

Meanwhile, Norfolk and Norwich University Hospitals said that as there had been no clinically significant changes, retests were not required. A spokesman said this was due to extensive calibration processes.

West Hertfordshire Teaching Hospitals Trust said it only lodged a complaint after hearing other trusts were affected but later found no issue present.

Bedfordshire Teaching Hospitals FT said it had enhanced quality control measures and implemented recommendations from field safety notices in full.

It said around 7,500 patients had been retested by the end of last month. A freedom of information request reveals fewer than five cases of patient harm – considered low – have been identified to date, although reviews are ongoing. 

Field safety notice

Trinity Biotech said it had received complaints over discrepant results from UK laboratories using the device in its field safety notice. It said there were concerns over a positive bias in results or differences between devices.

In a notice last month, it said: “The root cause investigation has determined that the system continues to operate within specification when operated per manufacturer’s instructions.”

Actions to be taken included preventive maintenance of devices, and a comprehensive training programme to be rolled out across the UK. 

In a statement, NHSE said: “The MHRA has reported an issue with a HbA1c (blood glucose) testing kit manufactured by Trinity Biotech – used in a small number of sites across the NHS – which may have led to false positive test results.

“The trusts impacted are reviewing test results and will contact anyone impacted directly, and patients should continue to attend their appointments as usual.”

Trinity Biotech declined to comment.