The death of a top Scots lawyer has prompted a criminal investigation amid fears a medical device malfunctioned and delivered a fatal dose of insulin as he slept.

Paul McNairney, 39, died last month after the US-made Omnipod pump delivered four days worth of insulin in less than an hour, according to data obtained by legal firm Digby Brown.

The advocate from the Gorbals in Glasgow received the device on the NHS and had been using it since July with no issues.

The pump is now undergoing analysis by medical regulators. The Crown Office confirmed it has launched an investigation.

A spokeswoman for Insulet, which manufacturers the device, said at this point it has no evidence a malfunction occurred but said further analysis will be conducted upon receiving the pump.

Meanwhile, Mr McNairney’s widower Scott Craig, 42, has called on health boards to suspend the use of the devices until their safety can be “guaranteed”.

He said: “This device is used worldwide so people need to know what happened as even a single avoidable death is one too many.”

The lawyer, who was diagnosed as a Type 1 diabetic at the age of two, was used to injecting himself with insulin four times per day and wore a sensor on his arm to track blood sugar levels.

But he wanted an Omnipod – a wearable pump that delivers insulin automatically – as it removed the need for numerous injections and came with a companion device to track data.

HeraldScotland:

Insulet, the Massachusetts firm that makes the pods, makes new users complete practitioner-led training before they get their device.

Mr McNairney completed this training and on July 12 started wearing his pod after it was supplied by NHS Greater Glasgow & Clyde. He got married four days later and used the pod without issue and enjoyed the freedom it gave him.

However, on Sunday, November 7 things went wrong.

Mr Craig woke that morning around 7am and left his husband to enjoy a lie-in following a busy week.

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At 10.30am he looked into the bedroom and saw his husband was still lying in bed so he continued to let him relax.

But at 12.30pm when he re-entered the bedroom he found him dripping with sweat and pale.

After five years together he knew this was a sign his husband was hypoglycaemic so he used an emergency glucagon syringe.

He said: “I’ve helped Paul before when he’s been hypoglycaemic – it’s something every partner of a diabetic gets used to.

“It should have made Paul come round in a few minutes but there was no response.”

He called an ambulance and on arrival paramedics injected Paul with a massive dose of glucose that should have made him bolt upright but again nothing happened.

Mr McNairney was taken to the Queen Elizabeth University Hospital but after several days in intensive care it was confirmed the advocate had suffered catastrophic and irreparable brain damage.

He passed away on Wednesday, November 10 after the decision was made to turn off his life support.

Mr Craig said: “Paul was intelligent, kind and calm. He was also uncommonly humble and could instantly be friends with anyone.

HeraldScotland:

“As well as the loss it’s the questions that makes things worse.

“There is no way Paul died because of an oversight on his part. None. It’s just not possible.

“He managed his condition his whole life and used syringes for years without issue but died within months of using this pod? This is more than coincidence.”

An exact cause of death is still to be confirmed but Digby Brown Solicitors say they discovered alarming data.

In a typical night the pod should automatically administer 0.55 units of insulin every hour while someone sleeps – this is called a ‘basal dose’.

HeraldScotland:

At breakfast the pod should then deliver 1.15 units to balance blood sugar with food intake – this is known as a ‘bolus dose’.

But records from the pod’s companion device shows that at 8.40am Mr McNairney received a bolus dose of 16.9 units – enough to put him in a coma.

The pod then administered three more bolus doses – each at 17.05 units – over the next 48 minutes.

Quadruple bolus doses combined with the basal dose meant he received 75 units – the equivalent of four days’ worth of insulin.

Lawyers say he could not have administered these doses as he’d be physically incapable and a working Omnipod is designed so it cannot deliver more than 30 units in one hour.

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Mark Gibson, Head of Product Liability at Digby Brown, said: “As I understand, the medical device is indeed being analysed by the authorities for any part it may have played in the death of Mr McNairney and in the meantime we will continue to support his loved ones and help them get the answers they deserve.”

A spokeswoman for Insulet said:"Consumer safety is Insulet’s number one priority.

"Our products are highly regulated, and we have comprehensive controls and procedures in place to ensure the safety of our products. 

"Insulet has been made aware of this unfortunate incident and is working with the Ministry of Health and Regulatory Affairs (MHRA) in the UK to obtain the device for further investigation. 

"At this point, we do not have evidence of a device malfunction or performance issue. 

"Further analysis will be conducted upon receiving the device.

"We extend our deepest condolences to Mr. McNairney’s loved ones at this difficult time."
A spokesman for NHS Greater Glasgow and Clyde said:”An investigation into the death by the Crown Office and Procurator Fiscal Service is ongoing and, as such, we are not able to comment further at this time.”

A spokesman for NHS Greater Glasgow and Clyde said:”An investigation into the death by the Crown Office and Procurator Fiscal Service is ongoing and, as such, we are not able to comment further at this time.”