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.
Did they say whether there is a time delay before the pump stops delivering basal?
I think that could end very badly if it happened unexpectedly while sleeping. I sometimes start to feel nauseous within 3hrs of applying a bent cannula… a potential 10hrs of no insulin seems dangerous.
There is no explicit mention of a time delay. Their message says: “If a Malfunction 16 is declared on your pump, insulin delivery will stop, and the pump is no longer operational.” I’m assuming that means I need to be prepared for an immediate stoppage, but the message does leave the door open to some delay.
The link in the first line of the opening leads to a check on your pump’s serial number to see whether it might have a compromised speaker. Mine did not so check and perhaps ease some worry.
I always carry insulin and a syringe. I keep both humalog and Lantus with me. I actually needed to switch when i lost my pump on an airplane. I don’t know what I would have done if I didn’t have the back up plan.
Also you can draw from your pump reservoir with a standard insulin syringe, I’ve done that at least twice.
With technology, you can’t just expect it will always work, ever pump I’ve had had a couple of failures.
My T2 was the only one that never truly failed. I had to get it replaced because the charging port was intermittent, and did that twice.
My Medtronic pump had a failure of the motor while changing cartridge.
My animas pump failed a lot and the housing cracked open a few times.
Of course I have had a few omnipod failures too.
This appeared on a well known SM site 2 days ago (I’ve deliberately not given a link for obvious reasons):
tandem employee here (unofficially of course), the problem is only gonna be solved with a replacement pump so if you aren’t comfortable with living with a wiring issue that could possibly at some point cause a malfunction, just call CTS for a replacement and it’ll be replaced.
There’s also the thing in the email about there having been 700 failures and 59 injuries. It’s not clear to me why a pump would ever have a “speaker” but I couldn’t find a teardown of the T.slim:x2 anywhere to find out what it is.
I believe that the speaker is there solely to alert the user. The user needs to look at the screen on the pump to find out any details. Apparently they wanted a more unique sound (and lower reliability?) than a buzzer.
I’m happy Tandem is relacing your pump, but this particular issue has nothing to do with the pump or the speaker. That’s all on Dexcom or Libre. The arrow comes direct from the CGM. Removing the arrow is an intentional safety feature. It means the raw data is a little erratic and Dexcom/Libre aren’t fully confident in the number being displayed. Per the manufacturer instructions, you’re not supposed to dose insulin if there’s no arrow, but rather fingerstick to verify first. Control-IQ also won’t make adjustments using those numbers. If the raw data is REALLY erratic and the sensor doesn’t trust it at all, the next step is the three dashes instead of a number, “- - -”.
Thank you, Robyn, for that information. I recently got the 3 hyphens (—) right after the 2-hour g6 warmup. I called Tandem Customer Service and was told to wait a bit and it might resolve itself. It did. But this time there was also no smoothing on the graph line. So I assume these were all due to Dexcom. Good to know.
When I received and installed the replacement Tandem pump and gave it the already installed transmitter and sensor codes, I was stunned to see that the entire day’s information was repopulated on the pump. The information had to have come from the transmitter. I did not know it had that capacity, but happy it did. This gives me a bigger appreciation for the role that Dexcom plays in concert with the Tandem CIQ.
The letter doesn’t mitigate their liability. They will still be on the hook for replacing pumps that fail. On several occasions, I’ve had errors that brick the pump, and they replaced it every time. The difference here is that they know of a specific problem and are getting the word out, probably as required FDA regs. If they had discovered that every speaker in the batch WILL fail, they would probably be required to issue a full recall. I think it reasonable that they don’t replaced pumps that may not ever fail.
That is exactly right. Affected customers have to be notified first - for obvious reasons and FDA within 30 days of customer notification so it remains to be seen how FDA will classify this recall (or field correction) and more importantly if FDA agrees with Tandem’s recall strategy. It could easily change or be expanded once FDA has their say.
