An urgent investigation was opened following the death of a diabetic Scottish attorney who died after a fatal dose of insulin.
Paul McNairney died last month after his Omnipod device malfunctioned before delivering four days of insulin in less than an hour in his sleep.
The 39-year-old was found in a coma by his loving husband Scott Craig, who was desperately trying to get him to stay before calling an ambulance to their Glasgow home.
But the lawyer lost his battle for life at Queen Elizabeth University Hospital on November 10 after spending several days in intensive care.
The heartbreaking decision to turn off his life support measures was made after medics discovered that he had suffered catastrophic and irreparable brain damage.
The lawyer received the device – a portable pump that automatically delivers insulin – from the NHS and has been using it since July with no problem.
However, after his death, the Omnipod was confiscated by the police and is now being analyzed by health experts.
The courageous widower Scott Craig, 42, would like to urgently draw attention to his fears that more people could be affected by faulty Omnipods.
He said, “This device is used around the world, so people need to know what happened because even a single preventable death is one too many.
“Paul was intelligent, kind, and calm. He was also unusually humble and could be instant friends with anyone.
“I don’t know how to get over it – we only got married five months ago. But besides the loss, it’s the questions that make things worse.
“I can’t get rid of the fact that I was sitting relaxed with the dog in the next room while my husband was dying in silence.
“But I don’t think Paul died because of an accident on his part. It’s just not possible. He has been in control of his condition his entire life and has used syringes with no problem for years, but died within months of using this capsule?
“I think this is more than a coincidence. I need to know how that happened. Paul’s family and friends should know. Other pod users need to know. We all deserve to know.
Paul, who was diagnosed with type 1 diabetes at the age of two, was used to injecting insulin four times a day and wore a sensor on his arm to measure blood sugar levels.
But he wanted an Omnipod because it eliminated multiple injections and came with a companion device for data tracking.
Insulet, the Massachusetts company that makes the capsules, has new users complete doctor-led training before receiving their device.
Paul completed this training and started wearing his capsule on July 12th after it was delivered by NHS Greater Glasgow & Clyde.
He married Scott four days later and used the capsule with no problems and enjoyed the freedom it gave him.
But everything went terribly wrong on Sunday, November 7th, after Scott let his husband sleep after a busy week.
At 10:30 am Scott looked into the bedroom and saw that Paul was still in bed, so he let him rest.
But when Scott came back into the bedroom at 12:30 pm, he saw that Paul was drenched in sweat and pale.
Scott knew immediately that this was a sign that his husband was hypoglycemic, so he used an emergency syringe of glucagon.
He said, “I’ve helped Paul before when he was hypoglycemic – every partner of a diabetic gets used to it.
“It should have got Paul to come in a few minutes, but there was no response.”
Scott called an ambulance and upon arrival, paramedics injected Paul with a massive dose of glucose that should have straightened him, but again nothing happened.
Paul was rushed to the nearby Queen Elizabeth University Hospital but died just days later before he was buried on December 15.
Scottish Police seized Paul’s Omnipod, which the COPFS forwarded to the Medicines and Health Products Regulatory Authority (MHRA) for investigation.
An exact cause of death has yet to be confirmed, but an early review by Digby Brown Solicitors revealed alarming data with Paul’s Omnipod.
On a typical night, the capsule should automatically deliver 0.55 units of insulin per hour while Paul sleeps – this is known as the “basal dose”.
At breakfast, the capsule should then deliver 1.15 units to balance blood sugar levels with food intake – this is known as the “bolus dose”.
But records from the capsule’s companion device show Paul received a 16.9 unit bolus dose at 8:40 a.m. – enough to put him into a coma.
The capsule then delivered three more bolus doses – each of 17.05 units – over the next 48 minutes.
Four times the bolus dose in combination with the base dose means that Paul received 75 units – the equivalent of four days of insulin.
A working Omnipod is designed so that it cannot deliver more than 30 units in an hour.
Mark Gibson, Digby Brown’s Head of Product Liability, said, “First, I recommend that Mr. Craig speak about the loss of his husband in hopes of helping others – it takes a lot of strength to do so.
“As I understand it, a medical device is actually being analyzed by the authorities for any role it might 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 that You deserve.”
An Insulet spokesman said: “Consumer safety is a top priority at Insulet. Our products are subject to strict regulations and we have extensive controls and procedures in place to ensure the safety of our products.
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“Insulet became aware of this unfortunate incident and is working with the UK Department of Health (MHRA) to obtain the device for further investigation.
“At this point in time, we have no evidence of a device malfunction or performance problem. “Further analyzes will be carried out after the device is received.
“Insulet has been developing, producing and selling the Omnipod® insulin management system safely and effectively for more than 15 years and it can be safely used as intended with a prescription.
“We extend our deepest condolences to Mr. McNairney’s family at this difficult time.”
An NHS Greater Glasgow and Clyde spokesman added: “Our thoughts and condolences go to the family and loved ones of Mr McNairney who continue to mourn his loss.
“An investigation into the death by the Crown Office and the Procurator Fiscal Service is underway and we have no further comments to make at this time.”
And a spokesman for the Crown Office and the Procurator Fiscal Service confirmed that an investigation is ongoing.
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