# faulty Silhouette



## chandler

Has anyone had a Medtronic Silhouette set come apart on them?

I was advised to try Silhouette instead of Mios by my DSN.  The first one (in my leg) was ok.  When I changed the set on day 3, the second set seems to have fallen apart overnight.  In the morning, I realised I was no longer connected to the pump because the tubing had come right out of the connector on my thigh while I slept - the two sides of the commection were still on my leg, it was just that the tube was ripped clean out.  

I found the pump at the bottom of my bed and my blood glucose was 16.5.  I suppose I could have rolled in such a way to cause this but it's not happened in a year of using Mios.  Just wondering if it's happened to anyone else?


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## Hanmillmum

Not had it happen with the Sils but exactly same thing has happened with the sure T's twice to us. It is the most frustrating part of pumping having a faulty cannula. I phoned Medtronic and have sent the problematic ones back (they sent a tube and pre-paid envelope to send to them). I try to remember to check for this prior to insertion but it's just yet another thing


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## trophywench

Good grief.

No sign of such probs with the Roche ones.


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## Redkite

Never in over six years of using Sils!  I think you've been very unlucky.


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## Riri

No - used sils for 3 years without a problem


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## chandler

Thanks folks.  I did contact Medtronic about it via their website but no response yet, that's what prompted me to ask on here.  Does sound like I've been unlucky, then.  I've kept the bits incase they want to see it.


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## HelenM

Just spotted this,
I woke up this morning to find that this had happened. I've been using silhouettes for over 6 years and it is a first.  Luckily I went to bed with a level of 90 (5mmol) and woke up at 130 (7.2) so it was more annoying than anything else.

 I once tried to take one apart because I wanted to try to use the tubing for something and it took a lot of force. I wonder if there is a batch with a  manufacturing fault.
I was debating whether to report it:  I'm not sure that I can explain it in French so I wonder if I could report it on the UK website.


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## Riri

Can you check the batch number both to see if it's the same?


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## HelenM

Batch no 5042562 (expiry 2018-09)


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## chandler

mine is different batch & expires 2019-01. finally got a reply from Medtronic today. Not helpful, suggests ensuring everything tucked into waistband at bedtime!

I shall raise a report on the mhra website. Perhaps you could do the same?


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## Hanmillmum

Funny how a few of us are suddenly experiencing problems with this on Medtronic tubing, wonder if the adhesive or whatever it is that binds them has changed. Do report it as they need to know if it's a widespread problem and not just occasional one off's - I was under the impression they would examine the faulty one's hence them sending a returns tube and form to fill in for ours :-/


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## chandler

That's me raised mine now,  you can do it online at 

http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyproblems/Devices/index.htm


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## chandler

Woke up this morning to find another broken Medtronic Silhouette infusion set.  Same as before, the tubing detached from the connector into the cannula.

Not the same lot number as last time.

Has anyone else noticed that Medtronic set tubing is now rough and opaque?  It used to be smooth and clear.  Just saying.


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## everydayupsanddowns

I've had some cloudy tubing and some clear tubing over the last year or two that Ive been using Sils. 

Never had a problem like you are describing though. Sounds grim.


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## chandler

I knew as soon as I woke up.  Felt sick, just like the bad old days before I got the pump.  Sure enough, high overnight blood sugar.

I've emailed Medtronic.  Luckily the wrapper was still in the bathroom bin.  It's not the same lot number as the box, this was the one they sent out as a replacement for the previous faulty Silhouette.  Consecutive lot numbers though.

I have sent Medtronic another email.

Here's what the failed set looks like.


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## Hanmillmum

chandler said:


> I knew as soon as I woke up.  Felt sick, just like the bad old days before I got the pump.  Sure enough, high overnight blood sugar.
> 
> I've emailed Medtronic.  Luckily the wrapper was still in the bathroom bin.  It's not the same lot number as the box, this was the one they sent out as a replacement for the previous faulty Silhouette.  Consecutive lot numbers though.
> 
> I have sent Medtronic another email.
> 
> Here's what the failed set looks like.



Chandler, this is exactly what happened to the sure T sets - at that exact same part, we had a spate of 3 within  a few weeks of one another. Nothing since. That was about 4 months ago. Not good enough Medtronic


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## Redkite

. That's terrible.  What do Medtronic have to say for themselves?


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## chandler

Hanmillmum said:


> Chandler, this is exactly what happened to the sure T sets - at that exact same part, we had a spate of 3 within  a few weeks of one another. Nothing since. That was about 4 months ago. Not good enough Medtronic




Did you report those failures to MHRA?  I logged last night's failure as another device fault.

http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyproblems/Devices/index.htm


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## chandler

Redkite said:


> . That's terrible.  What do Medtronic have to say for themselves?



No reply yet.  Last time it happened, it took them over a week to respond


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## Hanmillmum

I reported it to Medtronic and sent them in to them but no feedback. I will use the link you have given too if it's not too late to do so now.


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## chandler

I've been sent a big screw apart plastic tube in the post to return the ones that broke.  Hopefully they'll be able to figure out what's gone wrong.


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## Temujin

I am in California and I have been having this exact problem with Silhouette infusion sets for the last few months. MM has told me on the phone that they have no idea about this problem and insinuated it was because i "pulled on it." I have never felt more betrayed by a medical company, they know there is a problem and are denying it, I have returned five faulty tubing sets to them and have gotten no response other than two replacement sets. I am a 41 yo man and have been using Silhouettes for 12 years without problem until now.


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## everydayupsanddowns

I put an order in today and the Silhouettes came back as being 'out of stock'.

I've not heard of an MRHA advisory or anything though, so that could just be coincidence.


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## Temujin

Looks like I just connected with a bad customer service rep in July when I made my initial complaint. The guy I spoke with today was incredibly attentive and was very interested in getting the five additional failed silhouettes I have in my possession (not including the one from last night that left me at 450 mg/dl.) He also got my remaining boxes replaced with a different style of infusion set, a sof-set, which I haven't used for a long time but remember well. It is surprising to me how different the calls went, today the guy was positive and attentive, in July it was accusing and abrasive. The July guy told me that no problem existed and it was random as far as he was concerned, after twelve of the exact same failure from different lot numbers I'm relieved it is finally getting some attention. I'm reluctantly liking MM again, I'll post again when something else happens.


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## Pumper_Sue

everydayupsanddowns said:


> I put an order in today and the Silhouettes came back as being 'out of stock'.
> 
> I've not heard of an MRHA advisory or anything though, so that could just be coincidence.



There has been quite a few reports in the UK and USA about sets coming apart, so suspect the company is going to have to do something about it now.

Animas have had problems with the stick of some sets, I was fobbed off but soon found more than a few other animas users with the same problem.


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## chandler

Another one broken this week. Same place.


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## Hanmillmum

chandler said:


> Another one broken this week. Same place.



That's bad   !!! Not experienced any more faulty ones here as yet, touch wood.


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## everydayupsanddowns

Wow! That seems really unlucky. 

I've been using them for years and never had anything like this - I wonder how you can have had so many. Were they from the same lot number? Have you been reporting to Medtronic?


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## chandler

everydayupsanddowns said:


> Wow! That seems really unlucky.
> 
> I've been using them for years and never had anything like this - I wonder how you can have had so many. Were they from the same lot number? Have you been reporting to Medtronic?



Yes.  I've been reporting to MHRA, who then pass complaints on to Medtronic.  Medtronic were in touch today and are sending a canister so I can return this third one for analysis.  Still not heard back about the two I returned in the summer.

Two lot numbers were consecutive.  This one's completely different. All same expiry date though.

There are other people having the same issue if you do a bit of googling.  I've never had this problem with Mios, only Silhouette.


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## everydayupsanddowns

Hope you get some answers Chandler. Are you tempted to change set types? 

I'd be lost without silhouettes!


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## chandler

everydayupsanddowns said:


> Hope you get some answers Chandler. Are you tempted to change set types?
> 
> I'd be lost without silhouettes!



I did a whole year just on Mios and quite like them.  They're no use on my legs though, the cannula bends every time.  It's annoying that I'm heavily built and have big thighs but the underlying muscle doesn't let me use even a 6mm straight cannula.

Silhouette seems to be my answer to getting good rotation of sites. I've been requesting 2 boxes of Mio and one of Silhouette in my quarterly order to Medtronic.  Now that I've got the insertion technique sussed, I'm hoping this issue gets sorted so I don't have to go looking for a different set to use in my legs.

Do you use silhouettes for all your sites?


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## HOBIE

Have never used any other with No problems. At work am all over, under floors ,in lofts & gets knocked all the time without any problems !


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## everydayupsanddowns

chandler said:


> Do you use silhouettes for all your sites?



Yup. Have been doing so for a couple of years more or less.

Tried Mios but didn't like the the self-serter thinghy. Also tried Sure-T but wasn't keen on 2-day side changes and the extra loop.

Would prob have to use those though if Sils became unreliable.

Wish I knew what was behind your experience


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## chandler

Oh wow!  Look at this Medtronic link that's just appeared on my Facebook timeline.

IMPORTANT MEDICAL DEVICE SAFETY INFORMATION


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## Hanmillmum

Well thank goodness they are acknowledging the problem!! - hopefully they can fix it asap. Thanks for the link Chandler


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