# Medical device alert: Accu-Chek® Insight insulin pump system



## Northerner (May 12, 2016)

*Accu-Chek® Insight insulin pump system, manufactured by Roche Diabetes Care – risk of inappropriate treatment*
From:
Medicines and Healthcare products Regulatory Agency
Published:
12 May 2016
Issued:
12 May 2016
Alert type:
Medical device alert
Medical specialism:
General practice
Risk of a hypoglycaemic event if users misinterpret maintenance message ‘M-83 pump not able to complete task’. Users are advised to check pump history before re-initiating a programmed task (e.g. bolus delivery) MDA/2016/005.

https://www.gov.uk/drug-device-aler...diabetes-care-risk-of-inappropriate-treatment


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## trophywench (May 12, 2016)

I rather think anyone with half a brain would do that, TBH.

However I do of course realise that they must also cater for those who haven't!


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## HOBIE (May 13, 2016)

I would hate to think my kids were away from home & had that pump ??


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## trophywench (May 13, 2016)

Well hang on Hobie - the Combo and the Insight, both alarm -for instance - in the middle of a bolus or whatever else they happen to be doing, when the cartridge is getting low - the Combo was 20u, I have the Insight set at 10u now.  So as and when - I always check on the Pump history after, to make sure the whole bolus has gone in.

Do other pumps not alarm for any reason?

Isn't it just part of learning how to operate whatever pump you happen to have?  if they were little kids then I'd expect boluses to be supervised by the 'responsible adult' anyway same as they would for MDI.  So the designated adult would need to know what to do when the pump alarms, it's no different from his dad knowing what to do!


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## HOBIE (May 14, 2016)

I would hate to think one of my children were on a weekend break away from me & something happened with a faulty pump ?


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## Pumper_Sue (May 14, 2016)

HOBIE said:


> I would hate to think one of my children were on a weekend break away from me & something happened with a faulty pump ?


Then best give up pumping then or never allow a child out of your sight HOBIE as Medronic have a dreadful record with alarms/faults etc., with other pump companies in hot pursuit.

You have to remember the pump is a mini computer and they go wrong on occasions, hence why all pumpers are given strict instructions regarding carrying backup supplies.


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## trophywench (May 14, 2016)

Well exactly Sue - that's exactly why I not only carry pump supplies but also a packet of syringes with me.  (far easier to carry syringes than get scrips for all the garbage required for pens)


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## HOBIE (May 14, 2016)

I have been using a Medtronic pump for more than 9yrs. No problems with both models.  I will say again "I would not like to think a child of mine had a pump that was not up to scratch"


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## Northerner (May 14, 2016)

HOBIE said:


> I have been using a Medtronic pump for more than 9yrs. No problems with both models.  I will say again "I would not like to think a child of mine had a pump that was not up to scratch"


I don't think this is a problem with the actual pump, it's a problem with how some people react to the error messages, so they feel it needs clarification


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## Pumper_Sue (May 14, 2016)

HOBIE said:


> I have been using a Medtronic pump for more than 9yrs. No problems with both models.  I will say again "I would not like to think a child of mine had a pump that was not up to scratch"


Then you have been very lucky not to have needed a pump replaced. Perhaps if so concerned about the potential danger to children it might be a good idea to keep all children on pumps locked up at home or even write to the health sectary and suggest no child should have a pump just in case it goes wrong!


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## HOBIE (May 14, 2016)

Never needed to have replacement pump sue, Did you read the title of this thread ?


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## Pumper_Sue (May 14, 2016)

HOBIE said:


> Never needed to have replacement pump sue, Did you read the title of this thread ?


Yes I did read the title and you were implying that the Medtronic pump was perfect, which it certainly is not.


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## Sally71 (May 14, 2016)

We have had a couple of issues with the Combo Bluetooth dropping out just at the point when the bolus is due to start, so then you don't know if the pump has received the message or not.  Took me a while to work out how to check definitely whether the bolus has happened or not (and of course since then we haven't had the problem again lol). I can't follow my daughter everywhere though and certainly am not going to take the pump off her when she can't be with me!  Problems are rare and so I have to just hope that either it won't happen or that she'll use her brain if anything does go wrong.  If she goes hypo she'll deal with it.  If she didn't know whether the bolus had succeeded I think she would wait a while and then test and correct if she'd gone high.  Any adults in charge always ring me if they have any problem that they don't know how to sort out themselves.

I think it's very unlikely that we will choose the Insight as our next pump given all the bad press, but just because we haven't got that one doesn't mean we won't have a problem!  Someone on here (Flower?) has had two Medtronics waking her up in the small hours with pump delivery failure, which meant that she needed a new pump.  So they aren't infallible either Hobie! Nothing is perfect, but pumps are the best thing we have at the moment and I want my daughter to have the best, sometimes you have to take the rough with the smooth


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## HOBIE (May 14, 2016)

"I love my pump " & have never had a problem with it or the previous Medtronic


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## trophywench (May 14, 2016)

Sue and others were only pointing out that you are the exception Hobie - not the rule.  Lucky old you - but don't assume everyone else is automatically going to be that lucky - because they are simply - not!

When things are manufactured out of a pile of different bits and pieces - it's almost inevitable something will go wrong with some of them at some time!

"To err is human", after all ! - so even if the pump - or car - doesn't go kaput of it's own volition - very often add the human to the machine and they'll make it go wrong by doing something daft at some time, and break something on it anyway - even if it was perfect when it left the factory!


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## everydayupsanddowns (May 15, 2016)

I think all pumps have these kind of warnings issues every now and then - I've certainly had several issued by Medtronic over the past 5 years (and all of those seemed to be largely "Well duh! You just need to pay attention to what the pump is saying" things too).

One thing I didn't like with the Veo (and I'm not sure if the 640G is any different was what happened when you ran the reservoir almost empty. I tend to use 'low reservoir' alerts as my set change reminder, especially on the Veo where there was no other automatic option, which meant occasionally I ran the reservoir rather lower than intended. On the Veo it would go down to the last few units and then display -.--u. At that stage (if I'd made an error of judgement and was out and about) I was never sure if basal was still being delivered, but the pump didn't give any kind of warning/no insulin left alert. Initially I assumed it was actually out of insulin as it seemed to suggest and then 'topped back up' when I'd got back home and done a set change.

Having spoken to Medtronic though - it seems there is a secret buffer zone, past the point where the pump reads 'empty' where it will still be delivering basal. Obviously they dont want people to *know* about this - or they might come to rely on it and then run things even closer to the wire and get themselves in all sorts of bother. Helpful in its way... but not very clear  

I concede this was mostly a problem I created for myself... but just use it to illustrate that even when things are set up helpfully and with emergency (unpublished) buffer zones it's easy enough for users to get confused as to what is happening!


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## Sally71 (May 15, 2016)

That's interesting... We recently had "Cartridge Empty" alarm for the first time ever.  Which stops the pump - no arguing with that!
Normally we just change on the 6th day at tea time, it's usually close to or past the low cartridge alarm by then (20u). The lowest we'd ever run it down before then was 3u.  Last week apparently the low alarm went off at 5.45am, daughter in her sleepy state just turned the alarm off without checking what the problem was (probably just assumed that I'd put a TBR on and had misjudged the stop time) so didn't tell me, these days 20u is unlikely to last the whole school day so if I'd known I'd have changed it before breakfast. She came home from school, had a sandwich before her dance class and then the cartridge was empty, so it was "er, ok, I'll change it now then!"


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## trophywench (May 15, 2016)

Ah - an excellent point with the Insight then! - you can change the 'low cartridge' warning to a lower amount than 20u - which is two thirds approx. of my TDD, so I always ignored anyway.  Trouble is, subsequently forgetting you need to do it, as you say.  And it varied at where it decided it was empty - could be 5 point something u or could be zero u, or any point between.

At 10u which my Insight is now set at - I can assess where I am/where I'm going in the next few hours.  If that is at bedtime, I get a new cartridge out of the fridge before bed and leave it on my open meter case - so it will be one of the first things I see (after I've been to the loo LOL) next day.  I don't find slinging away less than 10u raises anywhere near as much guilt as just under 20u did, LOL


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## Sally71 (May 15, 2016)

You can change it on the Combo too, but can't do it on the pump itself - you have to have the computer software and do it that way.  Which we've never managed to do - because my hubby is a stickler for always having the latest version of Windows and Roche always seem to be playing catch up, we've never had a copy of the PC software which actually works on whatever Windows version we have!  Ditto the maximum bolus size - 12 units on my daughter's pump, which was obviously changed from the default 25 by someone because she was only 6 years old when she got the pump.  Which is just about ok now, but only just, we have had a couple of occasions when we had to do two boluses instead of one, because it was more than 12 units.  So will have to make sure that whatever pump we have next has the max bolus set a little higher!

Max bolus size is a safety issue, and I can imagine that some people might be a little gung ho if allowed to wildly mess around with certain settings, so I don't mind that one being a bit out of reach; don't see why the level at which your low cartridge warning goes off should be so hard to adjust though!


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## m1dnc (May 15, 2016)

trophywench said:


> "To err is human", after all ! - so even if the pump - or car - doesn't go kaput of it's own volition - very often add the human to the machine and they'll make it go wrong by doing something daft at some time, and break something on it anyway - even if it was perfect when it left the factory!



I've always worked to the maxim that "to err is human - but it takes a computer to make a real cock-up". When you put the two together, as with me and the pump, you can make a jolly good mess. I'm still here though.


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## SB2015 (May 15, 2016)

Sally71 said:


> . Which we've never managed to do - because my hubby is a stickler for always having the latest version of Windows and Roche always seem to be playing catch up, we've never had a copy of the PC software which actually works on whatever Windows version we have! Ditto the maximum bolus size - 12 units on my daughter's pump, which was obviously changed from the default 25 by someone because she was only 6 years old when she got the pump. Which is just about ok now, but only just, we have had a couple of occasions when we had to do two boluses instead of one, because it was more than 12 units. So will have to make sure that whatever pump we have next has the max bolus set a little higher!



Could you ask at your next consultant/ DSN appointment for them to change the levels.  They set up a few things at the start for me and I guess they will have access to 'hidden' settings.  I realise that you are about to change pumps so this idea may be a bit late.


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## trophywench (May 15, 2016)

There are a few things 'hidden' on the Combo that aren't on the Insight - provided of course that you still have W7 to enable the software !

 I deliberately haven't changed mine for that reason, but in any event W10 tells me the Graphics card in the PC won't support it - might only be a new driver, but there again might not - so no rush as far as I'm concerned.  I don't WANT programs to be renamed Apps thank you!


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## Sally71 (May 16, 2016)

SB2015 said:


> Could you ask at your next consultant/ DSN appointment for them to change the levels.  They set up a few things at the start for me and I guess they will have access to 'hidden' settings.  I realise that you are about to change pumps so this idea may be a bit late.


Oh that would have been a good idea wouldn't it, I never thought of that 
Thanks for the idea, but as you say probably a bit late now!


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## m1dnc (May 17, 2016)

trophywench said:


> W10 tells me the Graphics card in the PC won't support it - might only be a new driver, but there again might not - so no rush as far as I'm concerned.  I don't WANT programs to be renamed Apps thank you!



That's odd. I have W10 and have no problems with the Roche 360 s/w - very useful for adjusting basals in combination with  the Libre reports. I agree with you about programs becoming apps - or rather some programs becoming apps and the rest staying as programs. All very confusing.


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## Northerner (May 17, 2016)

m1dnc said:


> That's odd. I have W10 and have no problems with the Roche 360 s/w - very useful for adjusting basals in combination with  the Libre reports. I agree with you about programs becoming apps - or rather some programs becoming apps and the rest staying as programs. All very confusing.


That surprises me - when I used the 360 software I had to use it on my old desktop running XP, in no small part due to the fact that the infrared reader had a serial port connection which my laptop lacked! I presume it's USB now? Meter companies do seem to lag a long way behind when upgrading their software to new O/S.


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## trophywench (May 17, 2016)

The Insight is USB but the Combo (and I therefore suppose the Expert meter when it isn't a 'handset' for the pump?) is still infra-red.  However the infra-red doings, plugs into a USB port.

No idea how you use it on W10 - last year (having upgraded the software for the Insight) when W10 arrived 'all over' I rang Roche and asked them if there was a new version to download if I upgraded to W10, the answer was No but said they hoped it would be ready sometime next year, which is obviously now this year.  I haven't enquired about it since - but the box the CDs come in and the book, all say W7.  Mine came last May just after I got the Insight pump.  Perhaps someone who has had it recently could read their box and see what it now says?


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## m1dnc (May 17, 2016)

I don't really remember the transition from W8.1 to W10, let alone from W7 to W8, but to the best of my recollection I didn't reinstall the program. According to the 'properties' menu for the program it was installed on my machine in October 2014, and apparently is not running in compatibility mode (i.e. it seems to be running in 'native' W10 - don't ask me!). You could try using compatibility mode to run it as a W7 program - right click on the icon on the desktop or from the 'properties' menu.

Yes, Northie, the ir reader now has a USB plug.

As usual, the normal caveat applies. If it messes up on your computer, don't blame me!


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## trophywench (May 17, 2016)

We were on XP until it disappeared and never went to W8 at all, because we always wait when updates occur, for the glitches to be ironed out.  (as reported from various sources, quite a few of them programmers we know personally and whom we trust) Pete tried it on his lappy but could never get Office to work after that so we reverted to 7 until 10 was released.  Once we are pretty confident they have got rid of the glitches AND that it will improve our lives (LOL) then we have done previously.

10 won't download on this PC anyway - graphics card not up to it as I've mentioned previously.

Meanwhile W7 continues to work absolutely fine for me! - and if it ain't broke ........


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