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Important Update for Medtronic Customers

By Amanda Sheldon

Managing Editor

Posted:  6/10/2013 5:46 PM

Tags:

Here at Medtronic Diabetes, we’re committed to keeping customers like you informed about issues and solutions concerning our products and services. Your safety is absolutely our top priority, which is why I’m writing today to let you know about a potential safety issue and provide you with information on how you can avoid it.

While changing a Medtronic Paradigm infusion set, if insulin, or any liquid, gets on the inside of the tubing connector on Paradigm infusion sets, it can temporarily block the vents that allow the pump to properly prime. This can potentially result in the delivery of too much or too little insulin, which may cause hypoglycemia or hyperglycemia.

The potential for temporary blocking of the infusion set vents can be avoided by not allowing liquid to make contact with the inside of the tubing connector and by following the recommended reservoir fill procedure, provided to you when you received your pump and on our Website.

When the reservoir fill process and priming procedures are followed according to the instructions, the Paradigm reservoirs and infusion sets in the Paradigm pumps should work as intended. Because your safety is our number one priority, we are communicating to you — about both the potential issue and how to avoid it — both here at The LOOP and in a letter mailed to your home this week. We’ve also sent a letter to your healthcare professional about this potential issue.

As always, we appreciate your trust in us and are committed to supporting you in your diabetes management. You can find more information, including a downloadable copy of the letter you’ll receive this week and answers to a few frequently asked questions, here www.medtronicdiabetes.com/support/product-updates. Should you have any additional questions, please don’t hesitate to contact us at 1.888.204.7616.

On behalf of your Medtronic family,
Amanda

IMPORTANT SAFETY INFORMATION
- Medtronic Diabetes insulin infusion pumps, continuous glucose monitoring systems and associated components are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks associated with the use of these systems. 
- Successful operation of the insulin infusion pumps and/or continuous glucose monitoring systems requires adequate vision and hearing to recognize alerts and alarms. 

Medtronic Diabetes Insulin Infusion Pumps
- Insulin pump therapy is not recommended for individuals who are unable or unwilling to perform a minimum of four blood glucose tests per day. 
- Insulin pumps use rapid-acting insulin. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately. 

For more information, please visit www.medtronicdiabetes.com/importantsafetyinformation.


Comments

Nancy Gerdes

Posted on Tue Jun 11 14:29:35 GMT 2013

This is not about my pump but about the discontinuation of the sof-set.....I have been using them since I first got my pump and find it very disconcerting to have to try and use a new infusion set....as you must know diabetics are prone to decreased sensation not only in feet, but hands as well.....since this is the case with me it will be very hard to use the other infusion sets available,if I can use them....I really would hate to have to give up my pump...please consider this a registered complaint about the sof-set discontinuation...

Naomi

Posted on Tue Jun 11 15:25:24 GMT 2013

Hi Nancy, I know it’s disappointing when a product is no longer available and we do not make the decision to discontinue a product lightly. However, Sof-set is our oldest infusion cannula set and, unfortunately, we’re no longer able to manufacture it. We hope to make your transition to a new infusion set seamless and easy. We will continue to dedicate ourselves to advance diabetes management technology – including new infusion sets – to simplify life with diabetes. I’ll have someone contact you to talk about your options.

esther adams brown

Posted on Mon Jul 08 17:23:59 GMT 2013

still a diabetic and I'm still on insulin and pills I would like to get off

Verna Hatch

Posted on Tue Jul 09 16:36:30 GMT 2013

I do have, MMT - 326A Reservior's with Lot #8650428. As I have read your letter, I have determined that my units are OK. Please advise. Thank You, Verna Hatch.

Karrie

Posted on Tue Jul 09 18:12:07 GMT 2013

Hi Verna, thanks for the comment. We have provided an online tool at www.medtronicdiabetes.com/checklots. Please visit this site to determine how to find the lot number, enter the lot numbers from reservoir boxes you have on hand, and determine if you need to have any replaced as a result of this recall.

Kay Nusbaum

Posted on Thu Jul 11 06:03:04 GMT 2013

I do not hae any reservoirs with the affected lot numbers, but I do have a question - If you are to use a new reservoir for each new infusion set, why are reservoirs packed in boxes of 10 and infusion sets packed in boxes of 12?

Karrie

Posted on Thu Jul 11 19:01:28 GMT 2013

Hi Kay, thanks for the comment. I’m not sure which infusion set you’re using but our current infusion sets (Quick-set, mio, Silhouette, and Sure-T) do come in boxes of 10.

Karen Driskell

Posted on Sat Jul 13 02:13:14 GMT 2013

Please Help me order a new Clip or a Pink Case for my Insulin Pump Mine Broke today when i was working. Please Reply to me by Phone as soon as Possible.

Thank You,
Karen Driskell (Insulin Pump Paradigm 712)

Qudos

Posted on Sat Jul 13 20:37:54 GMT 2013

I don't have up to 5 available lots number , I just have 4 and I tried them in the check lots and they said according to the information that you have listed , you are not appear in the check lots list

Randy

Posted on Mon Jul 15 18:48:11 GMT 2013

I think it is sad thatminimed has not found a way that can make the pump talk.I think that would help me a lot.I do use the pump and am not able to read screen but I get through refillling and giving myself insulin with not to much trouble.I have been on pump sense 2000 all but for about 5 months,when a doctor saw me in medical center he said I should not be on pump he did not take the history of me bing on it for over 11 years as a blind user.

we can use the pump sure at times we need someone to read an error but that is not to offten
but a talking pump or a path to have the pump send info to my iphone would help me and lots of others deal better with pumping.
Randy

David Hartgraves

Posted on Tue Jul 16 14:54:04 GMT 2013

Thanks for the recall notice for reservoirs 326A. That's the one I use however none of my lot numbers were on the recall list. Thanks again for the notice.

Willie Harvey, Jr

Posted on Tue Jul 16 18:08:47 GMT 2013

I received the recall notice yesterday. I have been trying to talk to someone as to how I get the replacements for my reservoirs. I have the MMT-332A (3.0 ml). I have 65 of theses reservoirs (my complete supply for 2 months.) I have not disposed of them yet, but I can not use them. I am out of stock!! (HELP-HELP-HELP) I need theses reservoirs like yesterday.

Naomi

Posted on Tue Jul 16 18:14:39 GMT 2013

Hi Randy, thank you for the suggestion. I’ll be sure to pass it along to our product development team.

For additional information, please see http://www.medtronicdiabetes.com/ImportantSafetyInformation.

Naomi

Posted on Tue Jul 16 21:06:37 GMT 2013

Willie, I’ll have someone reach out to you shortly. In the meantime, please note that only certain lots of these reservoirs are being recalled. The Lot Number begins with an H. We have provided an online tool at www.medtronicdiabetes.com/checklots where you can determine how to find the lot number and enter the lot numbers from reservoirs you have on hand to see if they are part of this recall.

Patricia J. Hill

Posted on Sat Aug 03 14:15:59 GMT 2013

I was looking at some mail from this summer and discovered the Medtronic info about MMT-326A(which I use). . When was the info sent ? I don't know what the problem is but I have not noticed any problems with the reservoirs. Please inform me what I should do. I have one box and l reservoir left from my order.

Naomi

Posted on Mon Aug 05 15:58:10 GMT 2013

Hi Patricia. Thanks for your comment. We notified customers of this issue at the beginning of July and this recall involves only certain lots of reservoirs. For more information please read the Product and Service Update for our latest product updates on our website at http://www.medtronicdiabetes.com/support/product-updates. We have also provided an online tool at www.medtronicdiabetes.com/checklots where you can enter the lot numbers from the reservoirs you have on hand to see if they are part of this recall. We recommend you check all reservoirs you have on hand against the list online (or use the online verification tool on our website).

Marsha Wright

Posted on Mon Nov 04 19:07:21 GMT 2013

On Feb. 12th, 2012 my blood sugars were running in the 600's all day long. I continued to give myself insulin through my pump, but the sugar never went down. It c
blood sugar was over 990. I was in ICU on a ventilator all those weeks causing my family much stress. Due to the high blood sugar levels my organs started shutting down; my kidneys shut down. I went into congestive heart failure as well as numerous other dilemmas. They didn’t know if I would live or die.
I did come out of it, whatever it was, and am proud to say I’m a healthy diabetic of almost 62 years now. I do feel like my family and I are due some compensation for their long hours on the road and trying to stay by my side as often as possible. Needless to say, for that length of stay, medical expenses were costly. All of this was due to the use of the pump, which I no longer use.

Joel

Posted on Mon Nov 04 22:50:22 GMT 2013

Hi Marsha, I’m sorry to hear about this experience. I’ll have a member of my team reach out to you to learn more about what happened. If you have any unopened/unused reservoirs left from an affected lot, please make a note of the lot numbers and dispose of them right away. You can check to see if you have affected lots here: https://medtronicdiabetes.secure.force.com/medtronicdmcom/checklots

CHRIS

Posted on Wed Nov 20 17:40:31 GMT 2013

WILL MEDTRONIC EVER COME BACK OUT WITH THE SOF SET? I HAVE USED THEM FOR TWELVE YEARS AND LOVE THEM, I DO NOT CARE FOR ANY OF THE OTHER SETS, IVE TRIED THE QUICK SET BUT DO NOT LIKE THE HARD BULKY PLASTIC PART AGAINST YOUR STOMACH OR THE WAY IT DISCONNECTS, WILL THE SOF SETS MAKE A RETURN?

Joel

Posted on Wed Nov 20 22:49:35 GMT 2013

Hi Chris. I know it’s disappointing when a product is no longer available and we do not make the decision to discontinue lightly. Sof-set is our oldest cannula infusion set and, unfortunately, we’re unable to manufacture it any longer. We do have other infusion set options and we’re here to make the transition as seamless as possible. I will have someone from my team contact you to talk about other options.

MJ

Posted on Sat Mar 08 01:11:52 GMT 2014

I too am having problems converting to the new kinds of infusion sets. I am a 54 year insulin dependent diabetic and think the pump has made me a healthier diabetic BUT the learning curve and resulting high BGs have made a stressful life even more so. Why change a proven good thing? I am looking at other pump models but need the sensor to prevent nocturnal hypoglycemia reactions.

Joel

Posted on Mon Mar 10 16:15:18 GMT 2014

Hi MJ. I am sorry to hear you are experiencing problems converting to new infusion sets. I will have someone from my team contact you to try to help.

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