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FDA Warning Letter to Dexcom

Discussion in 'General Discussion' started by Ellen, Jun 1, 2010.

  1. Lisa P.

    Lisa P. Approved members

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    I'm glad to see the info because a broken sensor is something I'd like to watch for in my child.

    Those sensors slip out of the insert pretty easily, my assumption would be that more often than not it's not about a break but about the sensor wire staying in the skin instead of in the "sticker" part when the "sticker" is removed. But it's good to know to look for no matter what the case.

    However, my kids are pretty rough and tumble. I'm pretty sure they each have several splinters in their hands right now from climbing trees and playing with sticks and planks. Sure, the wire metal and sure, it's an infection and scarring risk, but I don't really see how this is any different from that -- you weigh the risks and the benefits, and minimize the risks as much as you can, and fix what you can of what gets hurt.

    I'd sure hate to have the FDA tell my kids tree climbing was off limits. :rolleyes:

    If regulators and Dexcom this as an opportunity to make a better product, that's fantastic. But if my kid can't get sensors anymore because of this, at some point, I'm going to be pretty unhappy (and put it in my manifesto).
     
  2. Daveb17093

    Daveb17093 New Member

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    This morning 7/13/2016 i changed my sensor and noticed the wire is completely missing and i have a big red bump on my skin. Im very nervous about this and called dexcom and the person said not to worry it can happen and they usually work them selfs out. I really dont feel comfortable with that answer and think it is healing over. I cant find any info on what can happen if it gets stuck in there. I will not use these on my child because im so freaked out over myself.
     
  3. rgcainmd

    rgcainmd Approved members

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    This is the first time I've ever heard of this occurring. We've been using a Dexcom CGMS for about 2-1/2 years and have had nothing but success. If you're worried about the filament not working its way out on its own, see if your doctor can remove it. If it were me, I'd give it some time.

    I'm not about to stop using this life-changing piece of D-tech based on one account...

    ETA: I have a bit of a problem with the fact that the post above mine was tacked onto a years-old thread that is not really related to Daveb17093's current issue. I'm pretty sure I'm not the only parent whose heart skipped a beat when I read "FDA Warning Letter to Dexcom"...
     
    Last edited: Jul 15, 2016
  4. Christopher

    Christopher Approved members

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    I agree with rgcainmd, go to the doctor if you are concerned. I have been on this forum for a long time and have never heard of this happening. Sound like a VERY rare problem. If you choose not to use it on your child that is obviously your call, but there are risks with everything in life. For me, even if I knew this was a documented problem that was happening to some people I would STILL use this on my child every single day. That is how useful I feel this product is.

    I also am not sure why it was tacked onto this thread and not just started as its own thread. Oh, and welcome to the site, Dave.
     
  5. Michelle'sMom

    Michelle'sMom Approved members

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    We've been using Dexcom a while now. We had a sensor wire break off a few years ago. I'd say about half the wire was left in her arm. We put Neosporin on it, covered it with a bandaid & waited. In the 3rd day, we were able to remove it with tweezers. It never caused any problems other than being a bit red. Since then I've been very careful about the direction I pull when removing the sensor. I'm almost certain that was the cause of the break.

    Earlier this week, the wire broke off completely from the sensor base during sensor change. It was barely under the skin so removal was no big deal. This was my dd's first attempt at inserting & removing a sensor on her own (she only uses arms). I watched her do it, so I know for a fact that she ignored my warning & pulled against the angle of the sensor.

    If you search specifically, you should be able to find at least a few posts about this. I know of one child with several broken wires who hasn't had any issues at all. Her ped said it wasn't worth the trauma of removing them as long as they're not causing problems.
     
  6. Michelle'sMom

    Michelle'sMom Approved members

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  7. Christopher

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    Yes, but these are from 5+ years ago. Are you continuing to have this happen recently? If so, I could see why you would be concerned.
     
  8. Michelle'sMom

    Michelle'sMom Approved members

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    I posted those for the OP who brought the thread back to, hopefully, demonstrate that it isn't reason enough to not use Dex. Obviously I have no concerns, despite having a recent issue, or my dd wouldn't still be using it.
     

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