Medicines board knew of blood test error

The State’s drug regulation body was alerted about a blood-testing kit error two months before a public notice was issued this week.

The Irish Medicines Board (IMB) confirmed yesterday that it was informed by the manufacturer of the kit in the last week of June.

According to the Health Service Executive, who issued a public statement on Wednesday, around 250 mothers and 290 babies could have been affected.

Of particular concern is that the blood group for 278 babies may have been reported incorrectly.

The IMB said it liaised closely with the manufacturers of the product — Ortho Clinical Diagnostics, a subsidiary of Johnson and Johnson — to ensure all hospitals here were notified.

The regulatory body said it received confirmation on July 5 that all of the hospitals who received potentially affected product had confirmed to the Britain-based manufacturer that it had received the safety notice.

The five hospitals identified were the Rotunda in Dublin, Cavan General, Sligo General, Limerick and Galway.

Asked about the delay in the HSE issuing a public notice, an IMB spokesman said it would have been expected that an exhaustive review of all hospital data and associated patient records would have been undertaken to ascertain where the potentially affected product was used.

However, a medical device alert regarding the kit was issued by the UK-based Medicines and Healthcare Products Regulatory Agency’s (MHRA) and posted on its website on July 26.

The IMB said it only posted safety notices in cases where the distributor of a product was Ireland-based.

It said existing lots of the kits were inspected by the hospitals and none were found to be incorrectly labelled.

The HSE said each hospital began contacting affected mothers on Monday and letters had been sent to anyone potentially affected by the manufacturing error.

At issue is an improperly positioned cassette label and its use may have led to potential misclassification of blood groups or incorrect antibody detection results for some patients.

According to the HSE, 30 mothers may have needed the blood product anti-D but didn’t get it, while 220 mothers got anti-D when they did not need it.

In addition to the 278 babies’ blood group results that may have been reported incorrectly, there were a further 12 babies who may have received red blood cells that did not need them.

The HSE said the risk of a baby’s blood group test result being incorrect was extremely low as the manufacturing error related to a label being incorrectly affixed to the test kit.