Sheffield & South Yorkshire

Insulin-free syringe firms fined over diabetic death

Two firms have been fined a total of £550,000 following the death of a diabetic hospital patient injected with insulin syringes containing no insulin.

Neil Judge, 58, from Barnsley, South Yorkshire suffered organ failure when he was injected with saline.

He was being treated at Sheffield's Northern General Hospital in 2010.

Sheffield Crown Court heard how the faulty syringes were supplied by wholesalers Fresenius Kabi Ltd for manufacturers Calea UK Ltd.

The Medicines and Healthcare products Regulatory Agency (MHRA) said Mr Judge's multi-organ failure was triggered by diabetic ketoacidosis because his body was deprived of insulin for more than 13 hours.

Triple dose

Last year, Sheffield coroner Chris Dorries ruled ketoacidosis from the manufacturing error was a "major contributory factor" in Mr Judge's death.

Fresenius Kabi, of Eastgate Way, Manor Park, Runcorn was fined £500,000 with costs after pleading pleading guilty to breaches of the Medicines Act 1968.

Calea UK, of the same address, was fined £50,000 with costs after pleading guilty to similar breaches, the agency said.

The MHRA said Calea also manufactured a batch of pre-prepared syringes administered to a patient with cystic fibrosis at the Royal Shrewsbury Hospital in 2011.

They were prepared and delivered direct for the patient and were found to contain three times the prescribed daily dose. There were no lasting effects in this case.

The court was told the two incidents followed a series of inspections by MHRA officials that highlighted deficiencies at the Calea and Fresenius Kabi site.

Alastair Jeffrey, MHRA head of enforcement, said the two companies were "equally responsible for the medicinal failure" that contributed to Mr Judge's death.

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