The death of Scottish lawyer Paul McNairney prompted an investigation

The death of a Scottish top lawyer has prompted a criminal investigation over fears that a medical device failed and delivered a lethal dose of insulin while he was sleeping.

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

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

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

A spokeswoman for Insulet, which manufactures the device, said at the moment that it has no evidence of a fault, but said further analysis will be performed upon receipt of the pump.

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

He said: “This device is used all over the world so people need to know what happened as even a single avoided 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 a day and had a sensor on his arm to track blood sugar levels.

But he wanted an Omnipod – a portable pump that delivers insulin automatically – as it eliminated the need for multiple injections and came with an accompanying device to track data.

HeraldScotland:

Insulet, the Massachusetts company that manufactures the bellows, gets new users to complete practitioner-led training before getting their device.

Mr. McNairney completed this training and began carrying his pod on July 12, after being provided by the NHS Greater Glasgow & Clyde. He got married four days later and used the pod without any problems and enjoyed the freedom it gave him.

On Sunday, November 7, however, things went wrong.

Sir. Craig woke up that morning around 6 p.m. 7 and left her husband to enjoy herself after a busy week.

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At 10:30 a.m., he looked into the bedroom and saw that his husband was still lying in bed, so he continued to let him relax.

But by 12.30pm, when he entered the bedroom again, he found him dripping with sweat and pale.

After five years together, he knew this was a sign that his husband was hypoglycemic, so he used an emergency syringe with glucagon.

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

“It should have made Paul come around in a few minutes, but there was no answer.”

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

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

He died on Wednesday, November 10, after the decision to turn off his life support.

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

HeraldScotland:

“Beyond the loss, it’s the issues that make things worse.

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

“He managed his condition all his life and used syringes for years with no problems, but died within months of using this pod? This is more than coincidence.”

An exact cause of death has yet to be confirmed, but Digby Brown Solicitors says they discovered alarming data.

On a typical night, the pod should automatically administer 0.55 units of insulin every hour while someone is sleeping – 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 bellows’ accompanying unit show that at. At 8.40, Mr McNairney received a bolus dose of 16.9 units – enough to put him in a coma.

The bellows then administered three additional bolus doses – each of 17.05 units – over the next 48 minutes.

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

Lawyers say he could not have given these doses as he would be physically unable and a functioning Omnipod is designed so that it can not deliver more than 30 units in an hour.

READ MORE: Scotland first in the world to launch a ‘life-changing’ diabetes test

Mark Gibson, Head of Product Liability at Digby Brown, said: “As I understand it, the medical device is actually being analyzed by the authorities for any role it may have played in Mr McNairney’s death 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 first 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 UK Ministry of Health and Regulatory Affairs (MHRA) to provide the device for further investigation.

“At this time, we have no evidence of a device error or performance issue.

“Further analysis will be performed upon receipt of the device.

“We express our deepest sympathy to Mr. McNairney’s loved ones during this difficult time.”
An NHS spokesman Greater Glasgow and Clyde said: “An inquiry into the deaths conducted by the Crown Office and Procurator Fiscal Service is underway and as such we are unable to comment further at this time.”

An NHS spokesman Greater Glasgow and Clyde said: “An inquiry into the deaths conducted by the Crown Office and Procurator Fiscal Service is underway and as such we are unable to comment further at this time.”


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