Diabetic Scots lawyer died after 'faulty' insulin pump delivered four days of insulin in an hour
An urgent investigation has been launched following the death of a diabetic Scots lawyer who passed away after receiving a fatal dose of insulin.
Paul McNairney died last month after his Omnipod device is believed to have malfunctioned before delivering four days worth of insulin in less than an hour as he slept.
The 39-year-old was found in a coma by his loving husband Scott Craig who desperately tried to bring him round before calling an ambulance to their Glasgow home.
But the lawyer sadly lost his fight for life at Queen Elizabeth University Hospital on November 10 after spending several days in intensive care.
The heartbreaking decision was made to turn off his life support after medics discovered he had suffered catastrophic and irreparable brain damage.
The advocate received the device - a wearable pump that delivers insulin automatically - from the NHS and had been using it since July with no issues.
But after his death the Omnipod was seized by police and is now being analysed by health experts.
Brave widower Scott Craig, 42, now wants to raise urgent awareness over his fears more people could be affected by faulty Omnipods.
He said: “This device is used worldwide so people need to know what happened as even a single avoidable death is one too many.
“Paul was intelligent, kind and calm. He was also uncommonly humble and could instantly be friends with anyone.
“I don’t know how I’m meant to get over this – we only married five months ago. But as well as the loss it’s the questions that makes things worse.
Digby Brown Solicitors Paul wearing his Omnipod device
“I can’t shake from my mind the fact that I was sitting in the next room relaxing with the dog while my husband lay dying in silence.
“But there is no way I believe Paul died because of an oversight on his part. 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?
"I think this is more than coincidence. I need to know how this happened. Paul’s family and friends need know. Other pod users need to know. We all deserve to know.
Paul, 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 as it removed the need for numerous injections and came with a companion device to track data.
Insulet, the Massachusetts firm that makes the pods, makes new users complete practitioner-led training before they get their device.
Paul completed this training and on July 12 started wearing his pod after it was supplied by NHS Greater Glasgow & Clyde.
He married Scott four days later and used the pod without issue and enjoyed the freedom it gave him.
But on Sunday, November 7, things went horribly wrong after Scott left his husband to sleep following a busy work week.
At 10.30am Scott looked in the bedroom and saw Paul was still lying in bed so continued to let him rest.
Digby Brown Solicitors Paul with devoted husband Scott Craig
But at 12.30pm when Scott re-entered the bedroom he saw Paul was dripping with sweat and pale.
Scott immediately 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.”
Scott 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.
Paul was rushed to nearby Queen Elizabeth University Hospital but passed away just days later before being laid to rest on December 15.
Police Scotland seized Paul’s Omnipod which the COPFS forwarded to Medicines and Healthcare products Regulatory Agency (MHRA) for investigation.
Dr Alison Cave, MHRA Chief Safety Officer, said: “Mr McNairney’s death is tragic, and our thoughts are with his loved ones during this difficult time.
“There is an ongoing investigation into his death under the direction of the Procurator Fiscal and so it would not be appropriate for us to comment.
Digby Brown Solicitors Paul and Scott had only recently married
"Further information should be sought from the Crown Office and Procurator Fiscal Service.
“People can be reassured we monitor the safety of all continuous insulin infusion devices.
"We ask anyone who suspects they have experienced an adverse incident linked with their device to speak to their healthcare professional and report it to us via the Yellow Card scheme.”
An exact cause of death is still to be confirmed but an early review from Digby Brown Solicitors found alarming data with Paul’s Omnipod.
In a typical night the pod should automatically administer 0.55 units of insulin every hour while Paul sleeps – this is called a ‘basal dose’.
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 Paul 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 means Paul received 75 units – the equivalent of four days’ worth of insulin.
A working Omnipod is designed so it cannot deliver more than 30 units in one hour.
Mark Gibson, Head of Product Liability at Digby Brown, said: “Firstly, I commend Mr Craig talking about the loss of his husband in the hope of helping others – it takes great strength to do so.
“As I understand it a 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 spokesperson 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.
“Insulet has been safely and effectively designing, manufacturing, and distributing the Omnipod® Insulin Management System for more than 15 years and it is safe to use as intended with a prescription.
“We extend our deepest condolences to Mr. McNairney’s loved ones at this difficult time.”
A spokesperson for NHS Greater Glasgow and Clyde added: “Our thoughts and condolences are with the family and loved ones of Mr McNairney as they continue to mourn his loss.
“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.”
And a spokesperson for the Crown Office and Procurator Fiscal Service confirmed an investigation was underway.
Reference: Daily Record: Sarah Vesty
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