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Important Safety Update for Paradigm Reservoirs

By Amanda Sheldon

Managing Editor

Posted:  7/5/2013 2:29 PM

Tags:

At Medtronic, making quality products that our customers can trust is our top priority. We are committed to improving our products, as well as communicating with you about potential issues when they arise.

As part of that commitment, we are voluntarily recalling certain manufacturing lots of the insulin reservoirs used with our Paradigm insulin pumps. This recall affects approximately 13% of the volume of reservoirs Medtronic manufactures in a year. We are being cautious and recalling certain reservoir lots that were manufactured between October 2012 and February 2013 that may have an increased potential for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if you have a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not alarm to notify you. We are being precautionary and have decided to recall all lots that have a possibility of being affected. We have now corrected this problem and implemented additional testing and inspection steps in our manufacturing process.

We are instructing all customers with reservoirs from affected lot numbers to discard these reservoirs and Medtronic will be providing replacement product to them at no additional charge.

For more information and to check if you have any lots of reservoirs that may be affected, click here http://www.medtronicdiabetes.com/support/product-updates.

We are dedicated to providing our customers with quality products and we thank you for putting your trust in us.

Comments

CAROL ALLEN

Posted on Sat Jul 06 04:35:03 GMT 2013

I have never used the insulin pump and do not plan to. Your representative could not take the time to go over things with me while I was off on disability and also my insurance did not cover her classes, but she offered them free, which was nice, but they were schedule while I was at work.

Tracy Friend

Posted on Sat Jul 06 16:15:38 GMT 2013

I checked all of my boxes, and they were all affected. I filled out the on-line form and sent it. However, I do not have any extra resevoirs. I really have not noticed more or less insulin being administered, so I will continue to use the resevoirs I have until new ones are shipped. I do want to note that my shipping address is different than my mailing address as I have dogs. I request my products to be shipped to a friend's residence to keep them from being chewed up. Please make sure this happens as in the past many shipments have been made to my residence and have been destroyed. If you have any questions please call at 219-241-6603...thank you.

Amanda Sheldon

Posted on Sat Jul 06 19:02:25 GMT 2013

Tracy, thank you for your comment. 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.

Diana L. Spegon

Posted on Wed Jul 10 00:20:13 GMT 2013

I'm not sure if my reservoirs are being recalled, I just received new ones a week ago,

REF: MMT - 332A
3.0ml
LOT H8595877 and H8732169

Thank You

Karrie

Posted on Wed Jul 10 18:45:38 GMT 2013

Hi Diana, thank you for the comment. We have provided an online tool at www.medtronicdiabetes.com/checklots. Please visit this site to determine how to 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.

Carol

Posted on Sat Jul 13 19:50:00 GMT 2013

Where is the on line reply form?

Karrie

Posted on Sat Jul 13 23:29:53 GMT 2013

Hi Carol - You can find the online form here: https://medtronicdiabetes.secure.force.com/medtronicdmcom/checklots

Karalynn

Posted on Sun Jul 14 15:35:54 GMT 2013

Hi my reservoirs were on the recall list, I responded the day I got the recall notification, I later found more boxes so I have 3 more boxes than I reported. I received one box yesterday from fed-ex so I will be okay for now. Thank you
Karalynn

Kim smith

Posted on Sun Jul 14 18:10:53 GMT 2013

I checked my reservoirs and none of my lot numbers were affected. However, for several weeks I have been smelling insulin on and around my pump. I had a battery alarm issue and my pump was replaced under warranty a couple days ago. I am now smelling insulin in the new pump. I don't see any liquid leaking but I do see bubbles in my tubing. Can anyone please help me. I don't wish my replacement pump to fail because of insulin leaking. Thanks. Kim. Also does anyone no if I can purchase an extended warranty on my pump?

Karrie

Posted on Mon Jul 15 15:34:36 GMT 2013

Kim - Thanks for reaching out to us. I'm sorry to hear about this. Someone from our team will reach out to you shortly to help you troubleshoot.

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