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[IP] =?UTF-8?Q?Fwd=3A_Urgent_Medical_Device_Recall_=E2=80=93_MiniMed_Infusi?= =?UTF-8?Q?on_Set?=



---------- Forwarded message ----------
From: Medtronic Diabetes <email @ redacted>
Date: Mon, Sep 11, 2017 at 3:01 PM
Subject: Urgent Medical Device Recall b MiniMed Infusion Set
To view this email as a web page, click here
<http://info.medtronicdm.com/v/K00hkKO00ped31bJd0mE0S0>

Medtronic is conducting a recall on infusion sets that you may have.
Because your safety is our top priority, we are sending you an immediate
replacement shipment of new and enhanced infusion sets.


[image: Medtronic logo]


Dear Valued Customer,

Medtronic is conducting a recall on infusion sets that you may have. In the
near future, you will receive an envelope from Medtronic which includes: a
Notification Letter, Key Steps for priming/fill-tubing, Frequently Asked
Questions, Return Instructions, and a prepaid return label.
Explanation of the Issue

Medtronic has become aware of recent reports of potential over-delivery of
insulin shortly after an infusion set change. Over-delivery of insulin can
cause hypoglycemia and in extreme cases, death.

Our investigation has shown this can be caused by fluid blocking the
infusion set membrane during the priming/fill-tubing process. A membrane
blocked by fluid most likely occurs if insulin, alcohol, or water is
spilled on top of the insulin reservoir which then could prevent the
infusion set from working properly. Infusion sets currently being shipped
by Medtronic contain a new and enhanced membrane material that
significantly reduces this risk.
Actions Required by You

   1. Go to https://checklots.medtronicdiabetes.com
   <http://info.medtronicdm.com/tbSd3h0eKJ0pX00EOk000m9> to determine if
   you have recalled infusion sets. You will be prompted to enter the REF and
   LOT numbers for all infusion sets in your possession. The website will
then
   tell you which infusion sets are part of this recall and which are not.

   Your REF and LOT numbers are listed on the labels as shown in the
   examples below:

   2.

   Medtronic recommends you not use recalled infusion sets.
   1. If you have new and enhanced infusion sets that are not part of this
      recall, use only those sets starting with your next set change. As a
      reminder, we have enclosed Key Steps regarding the priming/fill-tubing
      process.
      2.

      If you only have recalled infusion sets right now, *it is very
      important that you carefully follow the Key Steps*.
      3. Return your recalled infusion sets within the next four weeks
   using the prepaid label that will come with your notification letter.
   Medtronic will replace the recalled infusion sets free of charge.

Please visit https://www.medtronicdiabetes.com/notice7
<http://info.medtronicdm.com/iYeK0EOmdap00b000Jh3S0k> for more information
about this recall. This website contains: Key Steps for priming/
fill-tubing, frequently asked questions, return instructions and the
notification letter. Please be sure to refer to the Key Steps during your
next infusion set change.

All infusion sets you receive moving forward will be new and enhanced. It
is essential that you continue to order your infusion sets as you usually
do, even if you are expecting replacement infusion sets. If you have a
current supply order, do not cancel it.

We appreciate your time and attention to this important notification.

Sincerely,

Medtronic Diabetes


FREQUENTLY ASKED QUESTIONS
*Q1. Is this a recall?*

Yes, this is a voluntary recall because your safety is our top priority. We
are notifying all customers along with their corresponding healthcare
providers. You can check to see if your infusion sets are part of the
recall by visiting https://checklots.medtronicdiabetes.com
<http://info.medtronicdm.com/tbSd3h0eKJ0pX00EOk000m9>

Medtronic recommends that customers do not use and return any recalled
infusion sets they have. Medtronic will replace the recalled infusion sets
free of charge. Please be aware that the exchange process will take some
time, as we need to build the necessary inventory while ensuring supply for
ongoing use.

*Q2. What is better about the new infusion sets that will help prevent this
issue?*

The new and enhanced infusion sets being shipped to customers now have a
new membrane, and our investigation shows that this significantly reduces
the likelihood of a blocked membrane during the priming/fill-tubing process.

*Q3. How common is this problem?*

Out of the millions of infusions sets sold every year, the reported
incidence rate requiring medical assistance related to this issue is less
than 1 in every 2 million infusion sets. The new and enhanced infusion sets
being shipped today are not impacted by this recall. We are voluntarily
issuing this recall to ensure that our customers have the best products and
a good experience on insulin pump therapy.

*Q4. I am waiting for my replacement units to arrive. Can I continue to use
the infusion sets from these recalled lots? *

*We recommend that you do not use your recalled infusion sets and use only
new and enhanced sets starting with your next infusion set change.*

If you only have recalled infusion sets, *it is very important to carefully
follow the instructions within the Key Steps* regarding the
priming/fill-tubing process.

*Q5. What do I do if I donbt feel comfortable using the recalled infusion
sets until the replacement sets arrive?*

You may choose to revert to your back-up injection plan according to your
healthcare providerbs directions until your new replacement infusion sets
arrive.

*Q6. What do I do about ordering supplies? *

It is essential that you continue to order your infusion sets as you
usually do, even if you are expecting replacement infusion sets. If you
have a current supply order, do not cancel it.

Please note that replacement sets may take longer to receive than your
normal shipments. You may not receive all your replacements at once. All
infusion sets you receive moving forward will be new and enhanced.

*Q7. I do not have access to the website and I want to handle my returns
over the phone.*

You can always call us at 888-204-7616 <(888)%20204-7616> to speak to a
member of our team who can help arrange for your return and replacements.
We are, however, expecting a high volume of calls and recommend the website
as the first option.

*Q8. I want to receive training on how to prime my infusion set. *

Important information about how to prime your infusion set properly can be
found in the Key Steps instructions included in your recall notification.
In addition, Medtronic Diabetes has a host of online educational support
that you can access at: http://www.medtronicdiabetes.c
om/infusion-set-support
<http://info.medtronicdm.com/o03bE00Ze00mdK0kJSObhp0>


B) 2017 Medtronic. All rights reserved. Medtronic, Medtronic logo and
Further, Together are trademarks of Medtronic. All other brands are
trademarks of a Medtronic company.
940M17580-011 20170911


  <http://info.medtronicdm.com/qmSK0b0Jp00Eke03O0dc00h>
.
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