Unomedical Supplies' Inconsistent Quality

Been pumping 17 years. Medtronic, Cozmo (My favorite by far, nobody comes close), Animas, Meditronic and for the last three months Tandem.

I’ve used the 6mm 23" Insets (Medtronic) and T:90s (Tandem) along with the same from Animas & Deltec (can’t remember their names for them)

No big issues over the years, until now with Tandem. They flat out don’t stick and even with the think skin tape/covering (never needed it before) they don’t stick. The past three months for me have been Hell. I haven’t had sugars like this since I was first diagnosed 30 years ago.

I’ve tried the alternative Unomedical sets, but no luck with those. I am running 80-90% failure rate with the Tandems and yet had no problems with the same Unomedicals from the other pump companies.

Tonight was the last straw - I threw the pump hard, but my son caught it in mid-flight. I’m sending it back to Tandem and going with Medtronic just to get supplies that work.

I have a couple of nits to pick with Tandem on the pump, but nothing horrible. (Some Lawyer got into their UX design & it’s annoying.) But I can’t live with sugars in the high three hundreds and four hundreds. My family is tired of it all too.

Anyone notice a drop off in quality of Unomedical supplies in the past six months, no matter which pump you’re using?

I am using the tandem (unomedical) t:90’s and haven’t noticed a change in stickiness, but I always lay down skintac first, so may not notice regardless.

I have noticed that the white ball at the top of the t-slim’s cartridge, where you inject the insulin to fill the cartridge, keeps changing. It used to be a big puffy ball, and in the latest batch is flat and harder to push through. I’ve sent 1 back for a completely defective cartridge that was missing the injection hole all together.

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I wasn’t going to get into the pump issues, but you are right. I’ve had three of their cartridges where you flat out couldn’t inject any insulin into them.

The Tandem Rep asked me not to use SkinTac or Mastisol (I only did because the T:90s are not sticking at all) and to use the clear film patch over the inset. I’ve done that, but twice yesterday even with that over it, they just flopped off. There is NO stickiness to the T:90s. I had a box when I first got the pump in March like that, now three boxes I just received are like that.

I really believe the pump mfgrs should kick Unomedical for their QA, but given that it’s a near monopoly in the USA, I am reporting multiple adverse events directly to the FDA via MedWatch Online Voluntary Reporting Form

Strangely enough, I cannot find a single adverse event reported to the FDA about ANY Unomedical diabetes infusion sets! I will try other queries to MAUDE - Manufacturer and User Facility Device Experience, but something doesn’t smell right. MAUDE - Manufacturer and User Facility Device Experience

Did they say why? During my training this January, when I told her that I used skintac under my dexcom, she said I could use it on the infusion set too, as long as it didn’t bother my skin (bellies are more sensitive than arms).

She thought it was causing the set to come off. Go figure! I haven’t needed it, with the exception of when I knew I was going to spend hours in our pool. I’d use both to keep the set from coming off.

How weird skintac you have to pry the blasted infusion sets off, or have skin tac remover. I haven’t tried t’slims infusion sets but I’ve had more problems with animas not sticking well to me at all. I def use skintac far more with animas infusion sets than I ever did with Medtronic’s. Overall though I do love my tslim and have had very good numbers with it, but I did have to do a little tweaking initially. My carb ratio and correction factor needed changing on my tslim. I went from 1:10 carb ration to 1:8, and my correction factor went from 1:20 to 1:18, basal rates stayed pretty much the same, but I tweak those every now and then. Did the same with my Medtronic. I do think its more the delivery system for tslim. I think for some the micro delivery just doesn’t work as well for them.

I can’t see any difference between the Animas and Tandem other than the packaging. My guess is those sets come off the same line in lots, and get packaged. I’m thinking the pump companies have different vendor checking. As much as I never liked Medtronic’s pumps, their sets from Unomedical were almost 0% failure rate.

My father was a VP in aerospace and vendor quality checking can be extremely stringent (someone working on site) or loose (hey, if it doesn’t work then you will credit me against something that works.) I have no idea what’s going on, but these T:90s are absolute garbage.

I’ve found one effective adhesive trick that helps me a lot and doesn’t have much downside. I use hot water, soap, dishrag, and a hand towel. I wash, rinse well and then briskly dry with a clean and dry towel slightly abrading the intended site. Will usually make things stick for at least three days. Your experience may vary.

Terry, That’s good info for folks who have a problem with sticking. Plain old alcohol swab then wait until dry works well too. Unfortunately, none of that applies (no pun intended) when you’re trying to stick plain old cloth with no adhesive to skin.

These Unomedicals have no adhesive. It looks like many thousands across multiple lots.

Yikes! I guessed I missed that.

Question: You said you are sending the pump back and going back to Medtronic, are you able to get a refund for it? My impression has been that a pump purchase is basically no guarantee of satisfaction so if you buy it you are stuck with it.

Also, is there a reason you can’t just use other brands of infusion sets with the Tandem pump, such as using the medtronic ones with the luer lock connector?

I haven’t had any problems with the t:90s sticking, but I will say that I can only get about 1.5 days of wear out of them before my BG starts creeping steadily up and not responding to boluses… I am not sure that that is exclusive to those though, as I haven’t tested others recently. I used to use Ultraflex when I used the Accuchek pump, and could get 3 days out of them, but I did try one a while back and still didn’t get 3 days, so without more testing I am not sure. I will also say I am not crazy about paying so much money for supplies that are outsourced to cheap labor countries…

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Currently for the Tandem pump you can use any infusion set with a luer lock connector. With our Tandem X2 we are using up our remaining supply of Animas insets and see no difference between those and the Tandem insets. (Different color - nothing functionally different that we can tell.) They both work just as well - no obvious difference that we can observe.

Tandem has stated its intention to move to a custom connection for the Tandem cartridges which would then require you to use the corresponding custom Tandem insets. They have also stated they will allow the current Tandem cartridges with the luer lock to be availble for some time so as to allow people to use up supplies of infusion sets with luer locks they may already have on hand.

“Beginning in the second half of 2017, we intend to replace the standard Luer-lok connector that currently joins an infusion set to our cartridge with a custom connector, the t:lock™ Connector. Our t:lock Connector was designed to address the most requested improvement to our products that we have received from customers. It will be similar in its design to that of a standard Luer connector, but will, on average, reduce the time required to fill tubing by more than 30 seconds and reduce the amount of insulin used in the process by four and a half units. It will also reduce the likelihood that air bubbles will become trapped in the connector. We intend to offer our customers the same choice in infusion set configurations as they are able to purchase from us today, but with the added benefits associated with our t:lock Connector. However, we expect to offer customers both the original Luer-lok connector and our t:lock Connector concurrently for a period of time to facilitate the transition, and by year end we intend to only offer our t:lock Connector. We anticipate that the transition to our t:lock Connector will also result in an increase in our sales of infusion sets beginning in the second half of 2017. We intend to continue to invest in the development of enhancements to our infusion set products to address the perceived shortcomings of existing products on the market.”

I am in lockstep with you about the offshore manufacturing.
As it turns out, horrible timing on my part. Lost medical insurance due to wife being laid off from the Pharm Benefits industry, and my contract ending. So even if Tandem took the pump back, I can’t replace it.

I quit using it a few weeks ago and am back using syringes and a combo of long and short insulin. My sugar is back to normal and I feel 20 yrs younger. This entire episode was by far, the worst I’ve been through in 30 years of Type 1. No matter which pump mfgr and their own quirks, I never lost control of my sugar levels… Until now.

Well, everyone’s different and I know lots of people find a pump indispensible, but FWIW I have great success with MDI – emphasis on the M (unsurprisingly). I find pens and pen needles much more convenient than vials and syringes. I’ve been on the fence for years about switching to a pump but weighing all the advantages and disadvantages I haven’t yet found it compelling to make the change.

I can only speak for myself. I started on Jan 1, 2000 with a MiniMed. Didn’t bother to wait for training, I work in tech so I wasn’t afraid to figure it all out. My wife told me less than a week later “Wow! I have the old you back!” Pumping really made a positive difference in my life.

I went 17 years with no problems that affected my health until this mess. Sadly the monopoly in the diabetes infusion business seems to be causing quality problems that nobody at Tandem has decided is important. I hope the FDA steps in, and perhaps they will make some changes that forces alternatives to Unomedical.

Cant say that I’ve seen a lot of this issue – mostly because I’ve been using primarily older boxes of sets (I have an Animas pump). This week, however, I did happen to open a newer box – and this morning (second set from the box), I inserted one, only to have it ‘fail’ less than half an hour later. I blamed my shirt sleeve for pushing it out, but I’m uncertain whether it was simply not stuck on very well. The replacement one (wearing now) was from an older box, so I’m not sure if it’s just the one bad set or more yet.

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BINGO! I had no problems with the 4 yr old Animas versions that I originally used first (FIFO inventory) but as soon as I switched to the same set under the Tandem branding, it all went to (fill in the blank.)

I ordered three boxes as a follow on to the original single box because I knew that I was losing my insurance. ALL of the replacements had the same rotten no adhesive problem as the original single box.

The local Tandem rep tried like mad: had me try three to four other insets that I either had tried in the past (long days in our salt water pool caused me to check a few others years back), put a plastic cover over the t:90 sets, etc. She made three trips to my home.

Why? 17 years, no need for a local support person. No problems big enough to send someone out. Something’s wrong, and Tandem knows it.

Will they fix their mess?


I should probably call in the failed set to Animas, then. Hm… I’ll likely try another one from the same box today or tomorrow (depending when I decide to change it :slight_smile:) – will see what happens, but this is a concern…

If it’s an ongoing problem, I recommend filing your own adverse event report with the FDA. I have a feeling that reports by individuals get eyeballs looking at them: MedWatch Voluntary Report

I once mentioned a defective infusion set to Animas while ordering supplies. They told me that I should call in any infusion set that fails due to a defect along with the lot number of said infusion set.