For the first time in nearly six years (I’m on my second Tandem X2), the change cartridge process failed.
I was getting no insulin flow and the pump would not recognize that there was any insulin in the cartridge after the attempted fill.
I tried again with a different cartridge from a different box and lot number, same result.
I followed the correct procedure (as always).
I removed excess air first.
I filled it with 250 units.
I checked for a clear rubber o-ring left behind by a previous cartridge, there was none.
Tandem support had me remove the o-ring from inside the bottom of the new cartridge AND remove the rubber boot from the metal arm at the top of the pump (picture attached). the next try was successful, but I had questions that the Tandem tech could not answer. My questions to you:
Has Tandem ever advised you to remove the o ring from a cartridge before installing it? Did they give a reason? My rep was unclear “sometimes things happen”, was the answer they gave.
What is the purpose of the rubber boot (picture attached) and is it safe to run the pump without it? My best guess is for protection against water or dust, but again, the Tandem tech was unclear on both of those questions. I’d love to know for sure.
They have not gotten back to me yet with any answers. Thanks in advance for any knowledge you can share,
I would call them back and speak to a different person. I’d explain that we’re instructed to modify your pump and that the pump wasn’t FDA cleared to be operated without the o-ring and rubber boot. They owe you a new pump and replacement cartridges. Those parts are there for a reason. In reality, they’re probably not critical to safety, but a tech isn’t authorized to say that. Tandem as a company isn’t authorized to say that, unless they also submitted versions of the pump without those parts to be authorized.
Checking for an o-ring that isn’t supposed to be there is one thing, but requiring you to modify a regulated medical device is another. I have a hard believing Tandem would approve of what that tech told you. I don’t even think it’s legal. They are legally not allowed to tell you anything outside the regulated & approved materials. The manuals are part of the device approval process. (When I worked at a medical device company, we actually went through a recall because of a page break in the manual. Our competitor alleged it was “confusing” and could lead to misoperation just because the sentence carried over to another page.)
Thanks so much for taking the time to respond. When I spoke with Tandem this morning, it was clear that they were more than a little surprised by what I told them, and confirmed that it was an error on the part of the initial agent who worked with me. They processed return and my new pump is on it’s way.
I had the same issue with my T-Slim. The Tandem rep who talked me through it advised me to clean the area around the post that the cartridge sits on/snaps over (“post” is my term; it may not be the correct technical term) with an alcohol wipe, fill a new cartridge and repeat the fill process. That worked for me. Glad to hear you’re getting a new pump.
The T2 uses a different technology to keep it small. It basically uses a small plastic bag instead of a hard syringe. The problem is if that port on the side gets blocked, it can cause internal pressure that the pump can’t over come. That’s why they as you to remove that piece, to equalize the pressure. I had that happen too to me once, but it was fine after I put it back in.
That whole cartridge thing with the T2 was problematic for more than one reason.
I recently switched to MOBI and I don’t have the issues anymore, because it uses a syringe. You can actually see the insulin and bubbles and you can see how much insulin is in there. It is such an improvement, I wish they would bring that to the Tslim.
Changing the cartridge is also so much faster and easier.
Without that automated primimg that wastes insulin.
I could go on but I WONT. Happy with my Mobi. That’s a win.
