I received email from Tandem today (Voluntary Medical Device Correction). Apparently there may be a problem in the part of the pump that makes noise for alerts. But all they are doing is telling me that there may be a problem, they’re not offering to replace or repair the pump.
They also are informing me that if this problem does happen (the pump is unable to make alert noises) the pump will immediately brick itself, presumably keeping them out of legal liability. It doesn’t matter that the pump itself is still capable of working and knows that I’m still getting alerts through the phone app and that I have a CGM that is probably also delivering alerts. If the speaker seems to stop working Tandem ignores these alternative ways of delivering alerts and immediately kills the pump.
I have no doubt that their lawyers are happy with this solution, but I am not. Is shutting off my pump without notification (the speaker doesn’t work and that’s the only notification that they trust) really an acceptable solution? The pump knows it’s connected to my phone and has the ability to know that the app on my phone is connected to their back-end servers. The pump could automatically notify them that the speaker has gone bad and they could start the replacement process immediately without waiting for me to call. They could even call me immediately to confirm my shipping address without waiting for me to eventually notice that the pump has shut off, but they’d rather make their mistake my responsibility.
Instead of letting the pump continue to operate with the remote possibility that something might go wrong and I might fail to receive the relevant alert in spite of my connected phone, they guarantee that something will go wrong, possibly putting me in a life threatening position. But that life threatening position is now my problem and not theirs, so that apparently makes increasing the likelihood of a bad outcome a good idea.
If the lack of a speaker is really that critical, then they should replace the pump now. Alternatively, I’d be happy to continue to use this pump and depend upon my phone to receive alerts, and if the speaker dies I will ask for a replacement at that time. But I’m very unhappy being told that my pump may choose to commit suicide at the most inconvenient possible time not because it’s unable to work but simply because it can’t make noise at me.
Looks like someone has been tasked with finding bugs in the Dexcom systems; not necessarily the FDA or Dexcom. These things happen all the time now because “bug bounties” are paid to people (trivial amounts) if they can get a problem accepted as “serious”.
It gets weird because if a bug if found in a component then there’s no incentive to track down the faulty component. Indeed the opposite; a single supplier might have a whole defective batch, but that’s one “bug”; going after every user of that supplier makes much more money.
At least Dexcom are replacing all the receivers, but they’re dirt cheap so they would. It’s probably more of an issue for Tandem where the pump isn’t quite so cheap. I’m willing to bet half a pint of pale (winner collects) that the speaker failure rate is less than 1%.
The FDA requires that all of the safety mechanisms are working.
If the sound is off then you can’t get alerts. If you can’t get alerts you could die. So there is no way to get around that.
Even if Tandem was stupid enough to allow that, the FDA just won’t, too dangerous , forget the liability. The don’t want their pumps to be pulled from the market
I completely agree that what was done minimized dangers for the FDA and Tandem. I disagree that shutting off the pump because it can’t make any sound to alert the user that the pump is being shut off minimized dangers for the users. This response just makes it clear that this song and dance isn’t about the safety of the users.
I have (but don’t use) one of those receivers. I’ve heard about the recall (here among other places), but have never been notified.
I also assume that the failure rate is low. I just dislike Tandem covering their butts by sending out a letter saying “don’t worry, we’ll brick your pump if the speaker stops working.” As if that response does anything useful or good for me.
I received the Tandem email alert yesterday. Not knowing what a “speaker” was in this instance, I phoned Customer Service. I told them that I don’t have my pump connected to a cell phone. They immediately told me that I would get a replacement pump. The Dexcom problem was not a concern for me because I don’t use their receiver. I am satisfied with Tandem’s reaction even though it is a hassle to change pumps. BTW, my pump HAS been acting wonky lately by not showing the direction arrow off and on. I suspect the “speaker” problem extends farther than just warnings.
