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J and J not reporting pump problems?

Discussion in 'Parents of Children with Type 1' started by polly, Jan 11, 2012.

  1. polly

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    Just saw on the news that the FDA has warned J and J re: selling faulty pumps and delaying disclosures of injuries. Does anyone know anything about this? We purchased our ping last June and this is the first I have heard of it.
     
  2. BittysMom

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  3. jcanolson

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    Wonder if that has anything to do with the recent reports of problems with customer service operators when calling about a pump problem. I remember a few people posting about how many hoops they had to jump through to get a replacement.

    We've been with Animas for 6 years. I never had a problem with them until J and J took over. Sad.
     
  4. JaxDad

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    Wow, that's disturbing. We've not had problems with the keypad, but we use the remote much more frequently. About the only thing that is "good news" in the article is that some of the problems are acknowledged as user error.
     
  5. Lisa P.

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    Thanks for posting this.
     
  6. buggle

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  7. emilyandkevsmom

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    The following part of the article got to me: In a separate issue with the Animas insulin pumps, some pump keypads for controlling how much insulin is injected were deteriorating prematurely, leading to failures"
    "We decided to go with a new keypad because it's more durable," Pavis said
    But while Animas was lining up the new keypad supplier, it was still selling the older ones.

    Each time I called to get a replacement for this problem with my daughter's 2020 pump or brought it up at her endo's office I was told how "odd" this is that it keeps happening.
     
  8. Lisa P.

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    AFter the pump cartridge recall, which I believe was blamed on a new manufacturer, I wonder if there were changes where new suppliers and manufacturing facilities were switched to? It seems not impossible if when the recession hit someone decided to save money by buying from cheaper sources. But whadda I know, pure speculation.
     
  9. Lisa P.

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    This is why I'm glad to see this post.

    When we moved back to MDI from pumping, we were talked out of the move for months because the CDE couldn't believe the pump was a problem for us. When we finally gave up the ghost on it and things got better, she said another family said they had problems with the Ping and were quitting too -- but then said she was sure the problem was really sneaking food, not the pump. I think the assumption that equipment like this can't err or fail can get in the way of good management.

    Of course, you also don't want a panic where every time I get an exercise low or an adrenaline high I think the pump is malfunctioning, I get that. But still. . .
     
  10. Lisa P.

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    Wouldn't you think, though, that it wouldn't be a required report if it were just user error? I'm thinking user error that the design or a failure on the pump contributed to? For example, user pushed the wrong button, but because the keypad had worn or whatever?

    I don't know, I'm sure the FDA can overreact, but I also think it often has late underreactions.
     
  11. emilyandkevsmom

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    Lisa a completely understand why someone would chose MDI after pumping! I would have already went back but my daughter hates it soo bad so I keep trying with the pump. I feel that I have better control with MDI and it so much less stressful. I am not the one who has to live with this day to day and yes it does give her some freedom(when her pump is functioning properly) Not trying to start a MDI Vs. pump debate, I just wanted to let you know how much I understand your decision.
     
  12. Beach bum

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    So here is my question. If, this happened to one of us, can we file a report directly with the FDA? Is there a consumer complaint dept?
     
  13. MommaKat

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    The first part I quoted from your post makes me So mad. Sure, I understand that we need to consider all possibilities, and that in some instances a child might grab food and not cover (notice I avoid the word sneak. To insist an error is likely due to a child's deceitful action is just bad health care, IMO.

    The second part is just so true. When we make a choice to utilize technology for health care, it has to be taken with the understanding that technology does encounter blips and even fails at times. I don't understand why healthcare professionals are not more pragmatic about this. I encountered such a clear lack of acknowledgment of this on the part of doctors, nurses, health care administrators while doing disaster relief medicine. Medical care cannot take advantage of technology based tools without understanding a time will come when it fails to work properly, and back up interventions will be needed while the glitch is corrected, or the tool replaced. I think this is my number one reticence to moving towards pumping. If I felt that our care team respected that no tool is 100% fail safe, I'd feel so much better!!
     
  14. JaxDad

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    I think it would (and should) be a required report either way. In my company for example we have to record all customer complaints and determine their root cause. We have to take corrective actions and also preventative actions. In essence, if we find that there are several "user errors" we have to find a way to prevent them. And we're not associated with medicine in any way.

    It could be - or it could be the issue we discussed the other day, where the meter says "bolus not delivered - check the pump" when the meter and pump lose communication. If people believe the first part and don't do the second part - then that would be "user error" but the meter message could be the "root cause". A change in the message to be more clear would be the preventative action.
     
  15. selketine

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  16. sarahspins

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    Interestingly... I've had something like 5 pings replaced due to the button pad coming unglued (always near the OK button). I need to call in and get my current pump replaced, because guess what.. it's button pad is coming off too.

    It concerns me, honestly... because I feel like those things should last more than 4-5 months and I'm not particularly hard on them. The current pump I have (which was replaced after the battery compartment cracked) has lasted the longest... however it has still failed just like all of the others, plus most of the paint has chipped off... it looks like a mess.

    I want to like Animas, I do, and compared to the problems I had with my MM 511 and 512 pumps the button pad thing is relatively minor, but it just leaves me wondering just HOW hard is it to produce something that is actually reliable and will last more than a few months?
     
  17. Lisa P.

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    Oh, thanks, that's nice of you to mention.
    I sincerely, sincerely believe that different bodies work differently and sometimes a pump is better and sometimes not necessarily, and I think most people prefer pumping once they are on it. But I do mention our change back often because we spent at least a year pumping that we shouldn't have spent because I just kept thinking there was something I wasn't getting!
    Fortunately, Selah hates shots but every time we ask she wants to stay off the pump. I think somewhere in her she instinctively understands that she overall feels better off of it, right now.
     
  18. Lisa P.

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    That's interesting, I assumed Animas would only be responsible for reporting if they had some responsibility (even partial) for it, but I can see how reporting even when you couldn't have prevented it but can now prevent it because you have the information from the incidents could be helpful. Thanks for the info.
     
  19. Lisa P.

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    The USA story has been updated with a few more details. Here's a story about the way Johnson and Johnson has handled recalls and lawsuits on other products, and one about selling pumps with bad keypads after they knew it was a problem (headline a little deceptive, maybe).
    Looks like the user error was not responding to a pump alarm, I'm wondering if the user contests whether there was an alarm or did ignore it. It says the user ignored an alarm that the cap had come off the insulin cartridge, so I'm going to go out on a limb and say I suspect this is part of the defective lots of insulin cartridges they recalled (very poorly). I wondered if there were hospitalizations from those defects, and wondered if anyone would ever know if there were, since going into DKA would not be something you would attribute to a faulty insulin cartridge if you didn't know the cartridge might be faulty (I don't think my endo's office every heard about the recall, I only learned about it here). I'm guessing a lot of folks had problems they never knew were about those cartridges. Lack of transparency has consequences.
    Sorry, little miffed, and that may be misplaced. It's hard to get a true read on what's going on from news stories, maybe this is not that big of a deal, just the way things go sometimes.


    http://yourlife.usatoday.com/health...tive-recalled-JampJ-med-killed-son/52414134/1

    http://www.businessweek.com/news/20...pumps-after-learning-of-defects-fda-says.html
     
  20. MommaKat

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    I don't think it's misplaced, and this is where I have trouble with this. In nursing, both hospital and home care, we were instructed anytime there was a problem with medication (adverse reaction or event), or medical device that we had to report it - even if we thought user error was involved. The forms for filing these had places to list if user error contributed to the event and took scads of info - time, place, exactly what happened, any changes in health, or meds / devices / people involved. You name it, the form asked for it.

    While I was still in nursing the Institute of Medicine (IOM) and NIH conducted a study on reporting frequency in the early 2000s and found it severely lacking. Additional motivations and penalties to encourage reporting were implemented, and it is a really big deal for a hospital, doctor, device manufacturer, etc. to not report a device error and / or customer complaint that results in replacement of said device for even possible malfunction. Given the number of parents here and others on facebook who've complained about problems with the two models listed, I find it hard to believe we're only talking about 3 instances they failed to report.

    The defensive posture seemingly taken by J&J reps based on the article quotations from said reps is disconcerting as well. It just makes more sense for a company to say we've discovered a breakdown in communication of problems and are taking steps to rectify and properly train customer service reps in handling and reporting these complaints. That's the type of response that reassures consumers as opposed to we didn't do anything wrong, it was user error, our stuff is all up to code, blah, blah, blah.

    Okay, so that's JMHO, but seriously just be accountable and responsive. These are technical tools, and they're going to have problems. It's the response to those problems that truly matters.
     

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