Contact detach issue - Anyone else run into this?

Diabetes Technology Insulin Pumps
#1

Hey hey. I'm new here and haven't gone through everything so this may or may not have been brought up before.

Basically, over the course of the last few months we've noticed a few times when removing the contact detach from my son during a set change that the needle is nowhere to be found.

The first couple times (3 and 6 months ago), we thought perhaps it fell out when we removed it and the 6mm needle was in the carpet or something. I poked and pinched the inset site and asked if he felt anything to which he replied that he didn't. The most recent times, however, are a completely different story. July 4th and July 6th when we did set changes the needle from the contact detach wasn't there and when we poked/pinched my son said it hurt and felt like something was in there.

We called the endocrine team and they advised us to come in for x-rays to be sure. Well guess what....

My nine-year-old son has four 6mm needles lodged inside of him. At this point we've reported it to the FDA, contacted Animas and heard essentially nothing back, and we've switched back to the inset we used to use and are hoping to not run into the same issues we did in the past with kinked cannulas.

I'm curious to know if anyone else has run into or heard of this happening and what they would do if they were in this situation. Also, thanks for letting me be a part of your community. Hoping to make some good connections here.

#2

Wow! No, I never heard of such a thing (I use Contact Detach as well with no problems and vastly prefer it to the plastic sets which kink on me). My first thought was that it was a faulty batch, but you said it happened 3 and 6 months ago. I doubt you still have the boxes to check the batch number.

What is really disturbing is that you've gotten little response from Animas. I've called with much less critical sounding problems and gotten very good response. (Once I mentioned while calling about something else that when I changed the battery I had to reset the date and they sent me a whole new pump. Once I was questioning some high numbers and a person sat on the line and had me go all through my logs for quite a while). It sounds like you have had a lot of other problems with your pumps, could they have put you on some kind of "troublesome" list and are not believing you? Did you send them the broken off sets? That should have been the first thing they asked you to do. Are you still in warranty? Personally I would insist on some response from Animas. I wouldn't even bother with the agents who answer the phone but ask to speak to a supervisor. (That's always a good idea) I don't know if the FDA is the correct oversight agency for pumps, but if Animas doesn't respond I would find out who is and contact them.

I read your other post where you are considering stopping the pump. I understand you have other concerns, but I wouldn't stop the pump due just to this. Personally, I so much prefer Contact Detach to the plastic sets that I would really work hard to see if this is an anomaly (like a bad batch - which by the way you should get replaced free) before I even changed that, though I could understand if your son is squeamish about the metal needles now, I might be too! What a creepy experience for your little guy!

#3

Since Animas is only the distributer, I would contact Unomedical - the mfr. They are based in Denmark, but should still respond appropriately.

#4

Yeah my initial reaction was that it was more than likely a bad batch, but given the 6 month span I almost doubt it. I DID give them the batch info from the latest 2 incidents though and I have them both saved. They haven't asked for me to send them and at this point I'm a little hesitant to send them the only evidence of faulty equipment should this need to go further than just conversations (which I really hope it doesn't).

Animas has been really up and down with me lately. When it comes to normal reordering issues or incorrect shipments (which aren't often, but do happen occasionally for some reason), they're great and get the issue resolved quickly. However, when I brought up this obviously much more serious issue with the needles they have been very unhelpful. They are the ones who actually said they were reporting it to the FDA. I didn't even think to do that personally.

I certainly hope I'm not on some troublemaker list. I'm a pretty patient and level-headed guy. I have called 5 times since last week and I get put on hold for 30+ minutes each time. I feel pretty unimportant when I feel this is a pretty important issue.

Unfortunately we are way out of warranty. I don't even know what I want from Animas at this point except an apology maybe.... I mean what can they really do for me at this point?

We're considering stopping the pump for a lot of reasons, but this just kinda solidifies the idea. We used to be on insets but the cannula kinked frequently so we switched to the contact detach. Unfortunately, now with the issues of lost needles I never can trust that again, so we are back to insets. If they start kinking again though I don't know our next move.

All I know is that it's very scary and incredibly frustrating to see an x-ray of your child with 4 pieces of metal lodged in him that don't belong. Oh well, I guess I wait it out... :-/

#5

Just to clarify, I definitely wasn't saying you were a "trouble maker", just you had referred to several new pumps in a short time and I know how organizations tend to think/work...if someone has more than average needs or complaints they start to see them as a liability.

I definitely agree it's an important issue; yes, an apology would help, reimbursement or free supplies would help and at least some acknowledgment that something went very wrong. I'm not a parent so can only imagine how you feel seeing that x-ray. There are a lot of Animas users on this site, and if nothing else they should want to reassure their many customers.

#6

Also just because animas said they were going to report this to the fda as an adverse event do not assume that they really did so.
As the injured party you have the right to report it your self. Here it the link to the FDA reporting site. The fda will then be requesting info from the manufacturer and distributor etc.

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm

#7

I agree. I'm not sure who would be liable here, but it really seems like it would be the set manufacturer and not necessarily Animas.

#8

I figured you weren't calling me a trouble maker. I understand how companies think when they have someone who tends to have more issues than normal. And the thing about what to ask for is again, I have no clue... All of my son's supplies are covered by insurance and his pump was covered as well.

I guess I really am just looking for someone to explain why this may have happened and tell me what they're doing to make sure it doesn't happen again with my son or anyone else.

#9

Thank you for the link and thank you to the others helping me get correct info on this matter. I appreciate it.

#10

Just saw some one mention this on the tslim Facebook page. So you are not the only one having issues with needles separating from sets with the contact detach sets.

#11

Good to know but more upsetting to know there are more people out there experiencing this issue.

#12

I searched for adverse event reports and so far there has not been any reports of this issue. Please be sure to report to the FDA, so others become aware.

#13

I'm wondering how they are going to get those needles out of your son, or are they going to leave them? how frightening.

#14

I've heard of another child with about 6 needles stuck inside and needing to get surgery. You're not alone! Hope you get it all worked out!

#15

Well that's good to know in a weird kind of way...

As for now, the surgeons at the local hospital are thinking it isn't worth digging around in there and possibly causing unnecessary damage or scarring if the needles aren't bothering him on a regular basis. Sooo there's that I guess.

I don't even know what to do with this situation at this point. I'm confused and upset.