I received the following from Medtronic Canada today. I guessing all Medtronic pump users will be received something similar.

Dear Medtronic Customer:

Medtronic is committed to keeping you and your healthcare professional informed of issues and solutions concerning our products and services. The purpose of this letter is to inform you of a potential safety issue regarding the MiniMed Silhouette® and MiniMed Sure-T® infusion sets*.

As a part of our global quality monitoring process, we identified an increase in reports of the tubing becoming detached at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets (please see images below). While the number of these reports remains low, you are being notified of this potential issue because your safety is our top priority.

If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify you. The interruption of insulin delivery can cause hyperglycemia, which if left untreated, can result in diabetic ketoacidosis (DKA). DKA is a serious condition that can cause a severe impact to health, including death. Symptoms of DKA may include nausea, vomiting, shortness of breath and excess thirst/urination. Seek medical attention immediately if you are experiencing any of these symptoms.


What action do I need to take?

You do not need to return your product. You can continue to use your infusion sets while following the directions below.

1. When changing your infusion set, closely follow the instructions for use included in the product box Check the tubing at the site connector location identified in the drawings above to make sure it is not loose.

2. As always, it is essential to monitor your blood sugar levels frequently using your blood glucose meter. Proactively check your tubing connections occasionally to ensure tubing is secure. It is especially important to check your blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring.

3. If you experience a high blood sugar, check your tubing connections and infusion site closely to ensure your tubing is secure.

If you discover the tubing is detached:

1. Do not attempt to reattach the tubing. Replace the infusion set immediately.

2. Treat any high blood sugar based on guidelines provided by your healthcare professional.

3. Call the Medtronic HelpLine at 1-800-646-4633 to report the issue. We will give you instructions on how to return the affected infusion set to us.

We have identified a solution and are working to incorporate improvements. Healthcare Professionals have been notified. In the meantime, you will still be able to order these infusion sets. If you would like to try another type of MiniMed infusion set instead, please call our Consumer Care Team at 1-800-284-4416.

Managing marketed health product-related adverse incidents depends on healthcare professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health products. Any incident of serious or unexpected adverse incidents involving medical devices manufactured and/or distributed by Medtronic should be reported to Medtronic, and/or to Health Canada at the following addresses:

Medtronic of Canada, Ltd.
99 Hereford St. Brampton,
Ontario L6Y 0R3
Medtronic Diabetes Product Support Line
Tel: 1-800-646-4633

There have been posts about this problem on the Medtronic Pumpers Facebook page.

It's good that the people who had the problem reported it.

I've only had it happen once, and it was with tubing that was old and had been left unsealed. I thought it had tried out.

I had the same problem a few months back with a set that I'd been carrying around for a while in my luggage. Like Linda, I thought it was just too old. If it's a basic flaw in the set, the problem must have been going on for a long time.

I wonder if the same flaw exists in the Comforts which are actually the same as the Silhouettes, made by the same company.

I bet it does. I will make a special effort to pay attention to that connection. It was a high BG that got my attention when it happened to me, but I should have noticed the odor of insulin first.

I'm considering switching to the Cleos. I have never used anything but the bent needles, Sils, Sure-T's and, of course, Comforts but I tried a couple of Cleos, and while I don't like serters I sort of liked this one. The actual infusion set takes up so much less space than the Comforts.

I've had a lot of trouble with 90° insertion sets and serters. I evidently have a hide like a rhinoceros and almost no subcutaneous fat. (Lovely image, I know :-) I also have metal allergies so I feel I'm stuck with Sil-type sets.

Indeed. I had one such failure on a Comfort set tubing with my t:slim. It seems like it must be a relatively new problem as I never saw it in almost 5 years on Silhouettes and Sure-Ts with my Medtronic pump.

I don't have a lot of subcutaneous fat either but the sets I tried with the shorter cannula were okay. I still have a lot of Comforts so I am not giving them up but I might order a box of Clios. I just like the fact that are small. I'll probably stick with the Comforts. I have no problem with the metal. When I started pumping I couldn't use the Sof-Sets so my only choice was the bent needle and it was fine. I switched to the Sil when someone demonstrated it at a pump group meeting.

Tandem has now issued the same alert for t:slim infusion sets: notice. One interesting thing is that they named specific lot numbers.

This post has been edited by tedm: Nov 13 2014, 11:05 PM

Thanks, Ted. I didn't get the notification. I don't get my supplies from Tandem but I haven't heard from CCS Medical. I do use the Comforts but I don't have any boxes with those lot numbers.

It just happened to me. I changed my cartridge and set just before dinner yesterday and had a normal BG when I went to bed. My Dexcom woke me up with a SG of 205 at 5:30 am and told me my BG had been steadily rising since 3:30 am, which is not usual for me at all. I felt much worse than I would normally feel with a BG ~200 so I thought to check the tubing and saw it was broken where it attaches to the set, as advertised. All of my Comfort sets have one of the lot numbers listed in the warning. I've used ~25 of them or so without having any problems. Since none of the other kinds of sets seem to be a good option for me, I'd decided to continue using them despite the warning. 8 hours later, after changing my set and bolusing 3 units on top of the calculated correction bolus, I still have the headache and nausea typical for mild DKA. Just when I start to feel complacent about having everything under control, this nasty disease kicks me in the ...... again.

Where is the list of lot numbers for the Comforts?

I found it through the link that tedm posted: http://www.tandemdiabetes.com/Support/Noti...cation-Nov2014/

Thanks, Marty. I already checked that list. I am still considering switching to Cleos. I'm ready for a new order but I am going to try one more Cleo today.

I might have to do that, too, even though 90° sets haven't worked that well for me. I got the Comforts with the bad lot number from Edgepark. They've back-ordered Comfort sets now, probably because of this problem. I wonder if other suppliers have Comfort sets from good lots. (or I could go knock on the door at Tandem, which is just a couple of miles from my house.)