# Quite Concerning



## Kaylz (Dec 30, 2021)

Just saw this on the news tonight, definitely sounds like it may have malfunctioned! 








						Diabetic Scots lawyer died after 'faulty' insulin pump delivered fatal dose
					

Paul McNairney was found unresponsive by his husband at their Glasgow home on November 7 with preliminary examinations showing he had been given a massive overdose from his Omnipod device.




					www.dailyrecord.co.uk


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## Lily123 (Dec 30, 2021)

I feel so sorry for his husband and family. I wonder if it was just that Omnipod that was faulty or an entire batch of Omnipods that were faulty


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## Bloden (Dec 30, 2021)

Shocking!


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## grovesy (Dec 30, 2021)

Agree concerning!


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## Pumper_Sue (Dec 30, 2021)

I have just read the report as well. Medtronic was slated a few years back for an issue of dumping a bucket load of insulin.

Must admit I do wonder how it happens though because with the last 3 pumps I have had you set the amount the pump can deliver as a maximum bolus and maximum TDD as well as a maximum basal per hour. I assume this is a safety device. 

I'm confused by some of the reporting as it says the pump gave breakfast boluses yet the gentleman was asleep so was he using a closed loop system and did that malfunction? I also don't understand why his cgm did not alarm to say he was going hypo at 100mph.


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## Amity Island (Dec 30, 2021)

Very sad indeed. Something clearly went wrong, either programmed wrong or faulty machine or unknown reason?

It says this in the report:

"Records from the pod’s companion device shows that at 8.40am he 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 he 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"


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## nonethewiser (Dec 30, 2021)

Tragic so tragic, feel for those left behind.

Been using omnipod system for last 8 years, recently changed to dash device still using pods. Pods do have maximum dose to what can be delivered in 1 hour, also you can set maximum bolus dose so system wont deliver insulin if you accidentally enter wrong amount. Only yesterday went to deliver 5 units for lunch but entered 55 instead, message came up that dose was outside maximum bolus allowed which alerted me to mistake, so something horribly went wrong with this man's system for it to deliver that amount in 45 mins.


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## Inka (Dec 30, 2021)

Poor, poor man - just absolutely shocking. Deepest sympathy to his husband and all his family and friends. 

Previous issues are the reason the Omnipod is _not_ offered by my hospital.


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## Flower (Dec 30, 2021)

What a desperately sad situation, devastating and shocking for his husband, family & friends.


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## Northerner (Dec 31, 2021)

Terribly sad  I hope we get to hear what happened - often these stories appear bu we never get to find out the results of the investigation. It's important for users of this pump to find out how it might have happened.


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## grovesy (Dec 31, 2021)

Northerner said:


> Terribly sad  I hope we get to hear what happened - often these stories appear bu we never get to find out the results of the investigation. It's important for users of this pump to find out how it might have happened.


Very true!


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## Inka (Dec 31, 2021)

If it was a fault with the pump, surely Omnipod would have to issue an alert? 
This is a very worrying possibility - pump malfunction. Is it something Diabetes U.K. is watching @everydayupsanddowns @Cherrelle DUK ? 

I’ve had a tubed pump for many years. When I first got it, I was afraid of it pumping in an uncontrolled amount of insulin, but the pump rep explained my pump had two microchips and one was a ‘guardian’ one that was constantly monitoring the other. Do patch pumps have similar?


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## Bruce Stephens (Dec 31, 2021)

Inka said:


> If it was a fault with the pump, surely Omnipod would have to issue an alert?
> This is a very worrying possibility - pump malfunction. Is it something Diabetes U.K. is watching @everydayupsanddowns @Cherrelle DUK ?


Yes, it's important that at least Diabetes UK tracks what happens.

According to another report, https://www.thenational.scot/news/1...insulin-pump-ban-following-top-lawyers-death/
However, the pump manufacturer, Insulet, said it had no “evidence of a device malfunction or performance issue” currently and stressed that safety is its top priority.​but also
The legal firm said the pod then administered three more doses of 17.05 units each in the next 48 minutes.​​In total he is said to have received 75 units – the equivalent of four days’ worth of insulin, despite a working Omnipod being designed so it cannot deliver more than 30 units in one hour.​


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## stonefree (Dec 31, 2021)

Hang on , read the article before reacting this surfaced yesterday in the Herald . this has been floating about since November 10, it's now the  end of December.
Consider the timing,
At first the details  didn't add up.
between 20.00hrs and 08.00 the whole thing has been added to, and now the husband and the lawyers have been quoted
If you notice there is mention of criminal action,
plus the firm's Liability bod
It doesn't add up

What is strange is the time frame for the manufacturer to analyse the problem if it was a problem?

The husband is shouting for the pump to be withdrawn, I can accept that , but again I refer to the time frame,
Has the manufacturer sat on it's back side for 40 to 50 days?
Let's not kid anyone the pumps are big money to the manufacturer

Now a bit of background , in Scotland the SNP are promoting Diabetes as a disability , and there a lot of nasty people  . on that band wagon,
Any of the type ones I know would slap a wet mackerel round the ear of someone who said ,disabled
As for the Legal Firm . . . . Digby Brown     In the USA  it would be a Class Action Suit they smell,
The correct UK  title is "Group Litigation"
The removed post from the Herald


> "The article is a bit all over the place, on the face of it the pump seems to have over produced insulin, if the pump has failed and the result is that over production, then the simplest solution would setting the pump to default position of "off",on a failure within the system , then hyperglycemia would start to occur as opposed to hypoglycemia.As I said the article is quite vague
> Personally I have never fancied the pump
> and to be a bit tasteless what appear to have happened was used in Person of Interest ie phone, sensor and pump"


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## Kaylz (Dec 31, 2021)

There are quite a few Type 1's that think it should be classed as a disability from what I've seen on numerous groups, also sounds like a bit of Scottish battering going on in your post


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## stonefree (Dec 31, 2021)

No me , A'm the ane wha pointit oot thon the NHS wis predatit i scotland bi 35 years, somewhere on this forum

sae dinnae be givin me any o yer nonsense or ye'll no be gettin a Broons book for yer new year  noo awa hold yer wheesht
alba foundin member


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## mikeyB (Dec 31, 2021)

Well, I was classified as having a disability when I worked under Civil Service employment  rules in England. Indeed, it’s pretty normal for that to happen. I’ve always assumed it was enshrined in employment law.

Can I have the Broons Annual for my birthday?

I’m still an SNP member, read The National every day.


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## Inka (Dec 31, 2021)

*What is strange is the time frame for the manufacturer to analyse the problem if it was a problem?*

The pump went to the MRHA first. Nobody knows what happened so the death is unexplained and there has to be a criminal investigation. As it’s still being investigated, I imagine the article was worded and re-worded carefully so as to remain within the law.


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## Pumper_Sue (Dec 31, 2021)

mikeyB said:


> Well, I was classified as having a disability when I worked under Civil Service employment  rules in England. Indeed, it’s pretty normal for that to happen. I’ve always assumed it was enshrined in employment law.
> 
> Can I have the Broons Annual for my birthday?
> 
> I’m still an SNP member, read The National every day.


Nah it's just so they have x amount of people registered as disabled  It used to be the case where work places employing a certain amount of people had to employ a disabled person, oh then the bonus from the government for doing so


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## stonefree (Dec 31, 2021)

Inka said:


> *What is strange is the time frame for the manufacturer to analyse the problem if it was a problem?*
> 
> The pump went to the MRHA first. Nobody knows what happened so the death is unexplained and there has to be a criminal investigation. As it’s still being investigated, I imagine the article was worded and re-worded carefully so as to remain within the law.


Given they are the manufacturers , the initial report would within 10 days usually it would be quicker, , the final report a fair bit longer, that said I would have expected a reaction in the fashion of withdrawing the item, something like the warnings of say food from counters and the on doors of the stores.

The wording was changed dramatically  , it was about a third of the size of the one I posted that was taken at about 09.30 this morning
Criminal? The postmortem would give the cause of death , and if necessary lead to  further investigation , at that stage I believe it would not be a criminal investigation 
The Herald article refers to  a Liability  Bod( my word) , such a person would not be involved at this stage,as I believe any criminal proceedings would  reflect on liability .
I have concerns over blanket coverage by MSM


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## Docb (Jan 1, 2022)

May I suggest that speculation around this incident is not helpful to anybody, from those using similar equipment to the family of the individual concerned.  In particular it is not wise to treat newspaper reports as a primary source of information as they generally are more interested in creation the sensation needed to sell papers than anything else.

Leave it to those who have all the information available to come to a proper and reasoned conclusion and I am absolutely sure that if the focus falls on the equipment itself, the manufacturers will do all they can to help.  It is in their best interests. I am also sure that DUK will keep a watching brief on this incident and will broadcast anything relevant to the diabetic community generally when it is clear what all the circumstances were.


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## Leadinglights (Jan 1, 2022)

Docb said:


> May I suggest that speculation around this incident is not helpful to anybody, from those using similar equipment to the family of the individual concerned.  In particular it is not wise to treat newspaper reports as a primary source of information as they generally are more interested in creation the sensation needed to sell papers than anything else.
> 
> Leave it to those who have all the information available to come to a proper and reasoned conclusion and I am absolutely sure that if the focus falls on the equipment itself, the manufacturers will do all they can to help.  It is in their best interests. I am also sure that DUK will keep a watching brief on this incident and will broadcast anything relevant to the diabetic community generally when it is clear what all the circumstances were.


Well said !!!!!


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## stonefree (Jan 1, 2022)

What I'm saying is
This is nothing less than a quasi press release from some a group related to what appear to be ambulance chasers designed to cause panic and concern ,getting it into the MSM advances the "cause".
That cause appear to be a US court case,
As for the monitoring clause, or as you call it "a watching brief" that is only treading water,
Newspapers used give news, one would choose what to read dependent on your beliefes , idology , political or even religious views. they are not my concern.
But if this  ,at this time causes distress to Diabetics ,as it will . Paper should be callled out ,now
As for speculation, I have only stated the facts of the article in the Herald,whether I can get the original of that article.
Who knows?

But wheesht doesn't work

BTW. . . . Bruce Stephens post #13 gives the National's version via the link which is very close to the original one I saw in the Herald , there are some differences,The Herald owns the National, plus that one is as the Americans say it on the "wire"  or syndicated news


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## Pattidevans (Jan 1, 2022)

I do know a person who had a similar incident.  Her pump discharged a huge amount of insulin (it was not a pod pump but a tubed one).  Fortunately she was awake at the time and went to hospital where she was admitted  and stayed for several days.  @trophywench will recall the incident.  The person was a member of DSF and has since joined this forum.


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## Lily123 (Jan 1, 2022)

Pattidevans said:


> I do know a person who had a similar incident.  Her pump discharged a huge amount of insulin (it was not a pod pump but a tubed one).  Fortunately she was awake at the time and went to hospital where she was admitted  and stayed for several days.  @trophywench will recall the incident.  The person was a member of DSF and has since joined this forum.


@Pattidevans were they able to figure out what when wrong with the pump?


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## Pattidevans (Jan 1, 2022)

@Lily123 I can't remember and DSF has now  disappeared with all it's posts, but I am still in touch with the person and I'll try to remember to ask her.


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## GurjSooch (Jan 1, 2022)

I have considered asking for the Omnipod at clinic. This is worrying however


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## Lily123 (Jan 1, 2022)

GurjSooch said:


> I have considered asking for the Omnipod at clinic. This is worrying however


I’m worrying about that but if the Omnipod was to blame it would be a very rare thing to happen


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## Bruce Stephens (Jan 1, 2022)

GurjSooch said:


> I have considered asking for the Omnipod at clinic. This is worrying however


On balance I think it shouldn't worry anyone. This is an incident with one person, and we don't yet know whether the Omnipod was actually to blame. (I'm not suggesting it's pilot error. If Omnipod is designed in such a way that user can make such a nasty mistake then that's a fault with the Omnipod design.)


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## Pumper_Sue (Jan 1, 2022)

Bruce Stephens said:


> On balance I think it shouldn't worry anyone. This is an incident with one person, and we don't yet know whether the Omnipod was actually to blame. (I'm not suggesting it's pilot error. If Omnipod is designed in such a way that user can make such a nasty mistake then that's a fault with the Omnipod design.)


Also if you think logically if it was fault with the pump design there would have been one hell of a lot of incidences, and there hasn't been.


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## Hepato-pancreato (Jan 1, 2022)

Diabetes is seen as an unseen disability under the 2010 equality act.


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## GurjSooch (Jan 1, 2022)

Lily123 said:


> I’m worrying about that but if the Omnipod was to blame it would be a very rare thing to happen


Yeah this is a point. I will do some research first there are many different pumps, weigh up the differences


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## GurjSooch (Jan 1, 2022)

Bruce Stephens said:


> On balance I think it shouldn't worry anyone. This is an incident with one person, and we don't yet know whether the Omnipod was actually to blame. (I'm not suggesting it's pilot error. If Omnipod is designed in such a way that user can make such a nasty mistake then that's a fault with the Omnipod design.)


Absolutely


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## Inka (Jan 2, 2022)

Pattidevans said:


> I do know a person who had a similar incident.  Her pump discharged a huge amount of insulin (it was not a pod pump but a tubed one).  Fortunately she was awake at the time and went to hospital where she was admitted  and stayed for several days.  @trophywench will recall the incident.  The person was a member of DSF and has since joined this forum.



Can I ask what pump it was? I know there was an issue with a certain pump company and the FDA a while ago.

On a personal level, that must have been terrifying for the person concerned. Did she continue pumping or did that whole thing put her off (understandable if it did)?


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## Pumper_Sue (Jan 2, 2022)

Inka said:


> Can I ask what pump it was? I know there was an issue with a certain pump company and the FDA a while ago


It was a Medtronic pump


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## Inka (Jan 2, 2022)

Pumper_Sue said:


> It was a Medtronic pump


 
Ah, thank you  That was the company my careful wording was alluding to.


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## Pattidevans (Jan 2, 2022)

Inka said:


> Ah, thank you  That was the company my careful wording was alluding to.


Sorry, thought I had replied here.  It was a Medtronic Paradigm.  I spoke with her this morning elsewhere and she said the pump was returned to the hospital and all they have done is gloss over it since.  It has completely put her off ever pumping again and she is still on MDI.  I can't  recall when exactly it was, but it was a good number of years ago.


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## Lily123 (Jan 2, 2022)

Pattidevans said:


> Sorry, thought I had replied here.  It was a Medtronic Paradigm.  I spoke with her this morning elsewhere and she said the pump was returned to the hospital and all they have done is gloss over it since.  It has completely put her off ever pumping again and she is still on MDI.  I can't  recall when exactly it was, but it was a good number of years ago.


That’s a shame that it put her off using a pump although I’ve never heard of that pump


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## Inka (Jan 2, 2022)

Pattidevans said:


> Sorry, thought I had replied here.  It was a Medtronic Paradigm.  I spoke with her this morning elsewhere and she said the pump was returned to the hospital and all they have done is gloss over it since.  It has completely put her off ever pumping again and she is still on MDI.  I can't  recall when exactly it was, but it was a good number of years ago.



I remember the Paradigm  I don’t know if the FDA thing I recalled covered that pump - it was more recent, I think:

https://www.fda.gov/medical-devices...inimed-insulin-pumps-incorrect-insulin-dosing

Totally understandable why she’s on MDI. It sounds awful.


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## Pattidevans (Jan 2, 2022)

@Inka Yes, I remember those recalls with the different coloured retainer rings.



Lily123 said:


> That’s a shame that it put her off using a pump although I’ve never heard of that pump



@Lily, It  was over  10 years ago, so I guess you wouldn't have heard of it.


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## Lily123 (Jan 2, 2022)

Pattidevans said:


> @Inka Yes, I remember those recalls with the different coloured retainer rings.
> 
> 
> 
> @Lily, It  was over  10 years ago, so I guess you wouldn't have heard of it.


A fair few years then . I would have only been about 3 or 4 then.


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## everydayupsanddowns (Jan 2, 2022)

I had a Veo and really liked it. Early series Veos were quite popular with the looping crowd a while back I think, because they allowed remote control via rileylink or somesuch.


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