A 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.