Animas Corporation: Inspections, Compliance, Enforcement, and Criminal Investigations

Animas PingA friend of mine (thank you Trisha!) just sent me this link to the FDA website – Animas was sent a letter from the FDA because they failed to properly report insulin pump problems. You can read that letter here.

Unfortunately, that doesn’t surprise me. They have 30 days to report a problem to the FDA. When my pump failed, I started reading the MAUDE reports on the FDA site to watch for my pump to show up. Considering it over-dosed me with insulin and almost killed me, you think that warrants being reported to the FDA. My pump never showed up even though other dates after they received my pump back were being reported. Reading thru the FDA site, it appeared that only minor problems were being reported to the FDA. I doubt that either pump that was returned to them was ever reported to the FDA.

When my first pump broke, I was told by several people at Animas that I would be able to call them to get the results of their testing of the pump. I made several attempts to do that but I was never given that information. It is hard to wear a pump when you know that one almost killed you but the company that is making it would rather just cover that up than be honest about what happened.

Comments

  1. Very interesting. Somewhat scary.

  2. Scary!

  3. Kelly –
    My daughter has type one diabetes and an Animas insulin pump. Though I have not had experience with pump failure, I have had horrible customer service with Animas. Currently I am on day 25 of not getting my complete order of supplies. To say the least it is very frustrating. To top it off no one is apologetic and everyone I speak to including the supervisors don’t seem to care. I have conceeded to the fact that I am going to have to go through a distributor in order to get good customer service because I definitely haven’t gotten it from the manufactorer.

    • Korrin, I can’t remember how many months ago it was, but I know a lot of people in the Animas Group on TuDiabetes were having problems getting their supplies. They also complained about the lack of anyone returning phone calls or caring that they were out of supplies. Johnson & Johnson seems to have really gone downhill. Hopefully you can find a good supplier and not have to pull teeth to get the supplies your daughter needs. You shouldn’t have to go thru this!

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