I just saw this article this morning. Does anyone know anything more?
FDA: J&J Continued To Sell Insulin Pumps After Discovering Defects.
Bloomberg News (1/11, Nussbaum) reports on word from the FDA that "Johnson & Johnson's Animas unit kept selling insulin pumps last year after learning of malfunctions with the devices that prompted it to make design changes." The problems "with Animas' One Touch Ping and 2020 pumps prompted a company investigation that started in April, according to" an FDA "letter, which was dated Dec. 27." The December "warning could lead to fines or affect J&J's chances of winning federal contracts, the agency said in the letter."
I found this after looking at your post.
Hope this helps.
I think this the height of corporate irresponsibility--to continue selling a medical device that the company knows to be faulty. It's especially true given that the "...warning follows a string of nearly 30 product recalls announced by Johnson & Johnson since September 2009, that included millions of bottles of nonprescription medicines for children and adults, prescription drugs for seizures and HIV, faulty hip implants and contact lenses that stung the eyes."
One has to ask what is going on in that company. What are their priorities? Patient safety apparently is not one of them!
I just read the article online. Evidently J&J has really let quality control go in all of it businesses. While I have never had a problem with my Animas Ping, it is out of warranty and this really bothers me. I would really like to check out the Tandem if they would get that one out to the General Public.
The warning letter issued by FDA can be found at:
Wondering what the problem with the device is, or is this more not reporting problems related to misuse? Been working on the computer all day, too tired to read.....
I found this article to be helpful:
It turnsout there were two separate incidents:
Some pump keypads for controlling how much insulin is injected were deteriorating prematurely, leading to failures. But while Animas was lining up the new keypad supplier, it was still selling the older ones. The FDA demanded documents about the company's decision to do that.
Also, FDA inspectors found Animas never reported on three separate incidents, In one case the patient ignored an alarm signaling the cap had come off the insulin cartridge inside the device, preventing insulin from being pumped into the body.
I think most of the rports out there show that the pump user did something to enhance the situation.
I dont like things not being reported though, from any company.
It seems to me that those diabetics with the serious problems of high BGs, weren't checking their BGs often enough. When I get a high reading I will check the pump and then give insulin via a needle to bring it down. If it continues after that it certainly is a pump problem and a site change should be done.
I have one of these pumps. I have an IR1250 and I noticed the up arrow was harder and harder to push in. Sometimes it would seem like it work but then does not. I need to really watch it now. I called Animus and told them about the trouble not knowing about the lawsuit. and they told me my pump is out of warranty( which I knew) But my current one is not repairable. I'm getting a new one in the next week or so. They offered to rush be a loaner pump,because they didn't want me to have any problems. Of course I never heard back and I never got my loaner pump. My new one is set to arrive this coming Monday, so I will just get by until then. I do not know what pump I am getting as I have an odd insurance company, and they ask for my input but order one for me
I think They are NUTS for allowing another lawsuit to be possible for not acting. Luck for them I'm very aware of my pump and sugars.