The end of leaky reservoirs?


This is what has been happening to me every single time I take out a reservoir. I've had 2 replacement pumps sent to me and still get the same issue: http://www.tudiabetes.org/group/minimedparadigmusers/forum/topics/smelling-insulin-with-the-minimed-paradigm-523?commentId=583967%3AComment%3A3058604&groupId=583967%3AGroup%3A145829

so I was pretty excited when I got the tudiabetes email today about the Paradigm Reservoir Recall!
http://www.medtronicdiabetes.com/support/product-updates
Maybe all those canisters of leaky reservoirs that I sent Medtronic helped diagnose the issue!

Sadly, I typed all my lot numbers (and I have many different ones because Medtronic has sent me so many different replacement reservoirs) but none of them showed up as being affected :-(

I'm starting to think that I might have had 1 of the faulty reservoirs a while back (when I tried 3 different pumps) and it leaked so much that my pump still has insulin in the piston that it keeps showing up on these non-faulty reservoirs:





I even had the local Seattle Medtronic rep come over and watch me change my set (in case I was doing it wrong) but she was a stumped as every Medtronic rep I've talked to about this on the help line!

Has anyone else seen these insulin rings every time you take out your reservoir?

So far it appears I am fortunate not to have leaky reservoirs. But I will be watching them just to make sure. I feel lucky since the last recall of quickset infusion sets really through my supply for a loop. Let's hope this resolves this issue.
Christine

Do you push the plunger 3x before filling the reservoir? It lubricates the reservoir. I just learned this trick. Also I manually push about 1 inch of insulin from the reservoir into the tubing before removing plunger and putting reservoir into pump. This has helped prevent any bubbles.

Sorry you are having so many problems with leaky reservoirs. I can't offer a solution, but I appreciate the photos so I know what to look for.

Thanks for checking, Kate's Mom>
I was taught to lubricate by my CDE the very first day and do it every time. I even make sure not to squeeze the reservoir too much to make sure to not bend the plastic, in case that causes a leak.

When I changed my site in front of the local Medtronic Rep they said I did everything perfectly: we were of course both hoping that I hadn't!

What is interesting is that it happens after a few hours. I'll change my set, and then take the new reservoir out at the end of the day (to check) and they already have the ring of insulin in the above photos, just where the O-ring initially was.
It's really making me think that this leak occurs right when the pump and reservoir meet for the first time!

do you fill the reservoir completely? I only ask cause it makes me nervous to do so...it seems like the base of the stopper doesn't fit flush with the bottom when I fill to the 1.8 line (my daughter uses the 1.8)

We were probably taught to lubricate at training as well...but my daughter was still in her first year of dx and I was a bit overwhelmed! But we do it correctly now and have no issues.

Good luck and I hope you solve your problem!

Thanks!
I only need ~1.0, so I make sure to stay away from the bottom (for the exact same fear as you, don't want the lower O-ring getting too close to the bottom!)

I'm going to travel outside the country for 3 weeks next month (for the first time since I started pumping) and will get a loaner pump.
I will try the "new replacement reservoirs" Medtronic is sending me (I called them last night asking for reservoirs that they are SURE aren't faulty) with the loaner pump and I hope that will solve the issue.
I really hope it's just residual insulin from a previous leak that keeps showing up right at the start.

I do hope these are useful for everyone else to be on the lookout!

Call Medtronic Support and report these issues. Ask to speak to a Supervisor or Manager and mention that your problematic reservoirs are not on the Recall List. They may need to expand the recall.

Let them know you also have photos to submit. I'm not sure why they sent replacement pumps because it clearly appears to be faulty reservoirs, possibly O-ring failing to seal properly.

This problem should also be reported to the FDA: FDA MedWatch Report Serious Problem

I'm a mechanical engineer, so I just disassembled a recalled reservoir and a non-recalled reservoir and examined them both with good light and a magnifying glass. I can't see the difference. My motivation was the anger over just having finished my third box of of recalled reservoirs and having an A1C rise of 0.8 over the last three months. I'm just frustrated; which means this is a day like any other with diabetes.

Yeah, I called them last night to tell them mine are not on their recall list.

I've been calling them regularly every couple weeks about it, but every time it's with a different customer support person and I have to go through the explanation over again.

I've been in contact with my local rep, which is easier for me, since she understands that I've done everything correctly! I've sent her my photos, but look forward to discussing this recall with her next week.

It would really be tragic if all their reservoirs were previously fine, but suddenly they made a manufacturing change in October 2012 that caused this issue... and even worse that it took them this long to recall them (especially if there are still issues with the non-recalled ones)

I hope that isn't the case...

Yeah, me too. I was thinking it might be wise to stockpile a little bit just to give them time to do recalls in the future before I use the stuff. As for your leakage problem, two other things that may cause excessive pressure in your reservoir after priming your pump are rapid temperature increase and too much voltage. If you aren't using the basic AAA Energizer batteries Medtronic recommends, you may be priming too hard and getting a little "blowby" at the o-rings. Or, if you keep your insulin refrigerated until you fill the reservoir, the insulin wouldn't heat up until after you finish priming. If the piston is already in place, you would get a little back pressure after the heating occurs which could cause leakage.

I do use the Energizer Max batteries, and I let my insulin sit at room temperature for an hour before opening up my Mio set and priming with the pump.

I did think that could be a factor as well, so when I got to the end of my vial of insulin, I left it at room temperature for the last 2 weeks and still had the same results :-(

I have my rep on speed dial! I called him as soon as I heard rumors of a recall. I think everyone should know their local rep! Safe travels and good health! Keep us posted!

yup, mine look exactly like that. lot# H8595877 the ones i'm currently using.
and the 4 boxes i just got delivered were on the recall list.

I have had the same problem as you (and took pictures of the leaky reservoir as well). I had used reservoirs that were on the recall list prior to the list being created and saw the problem (but didn’t report it as I thought it was just a fluke and didn’t really think it was too serious although now, looking back on it, I realize that was a bit silly)… but recently used one that is not on the list and had the same problem. I was also told that I must be filling the reservoir incorrectly. This new reservoir, which leaked (I was woken up at 3:00 a.m. by my sensor - my blood sugar had gone up to 23.0mmols and then, I corrected via syringe and then I checked the reservoir and… yup… leaking!) is lot number: H8547298. I was told is not on the recall list and not made by the same manufacturer. I have to say, I’m frustrated by this and no longer feel safe. I’m thankful for the sensor, otherwise I don’t know if I would continue using the pump.

I am hoping this is the cause of my issues with my pump. I couple of months back I switched from an Animas pump to the Medtronic Veo to get the CGM. Since then my blood sugars have gone crazy. I can only think it is the leaky reservoirs, as I have been stable for years. I must say the constant alarms are driving me up the wall too, but I think I am past being able to return this thing. Let's hope things get better, because I am regretting my choice. On the plus side the CGM, has saved me from unexplained highs and lows. Let's just say I have little confidence in the pump at this time.

Graeme,
Did you have any problems with the animas pump? I just recently upgraded my MM pump to the revel. I checked out other pumps including the animas but because
of the CGM, I also decided to stick with the MM. I also have had good service. Their customer service are very well trained and supportive.
Anyway, I was just curious if they was any difference other than the CGM between the two brands.
Chris

I was on Animas for 7 years and had one replacement. I over tightened the battery cover and cracked the case. They sent me a new pump. Other than that, no issues.

I am back on my old Animas pump now, as MM support told me to stop using the MM, as I only had the recalled reservoirs. I am still waiting for replacement reservoirs!!!

I think the training was better with MM, but the support with Animas has been outstanding. The Animas pump also has less alarms and less button pushing. I also think the Animas is a more rugged pump.