[IPp] Recall for PARADIGM® QUICK-SET® PLUS INFUSION SETS
May 15, 2004
IMPORTANT RECALL INFORMATION:
PARADIGM. QUICK-SET. PLUS INFUSION SETS
Dear Paradigm Quick-set Plus Infusion Set User:
This letter is provided to notify you that Medtronic MiniMed is recalling all
Paradigm Quick-set Plus infusion
sets. If you have Paradigm Quick-set Plus infusion sets in your possession,
please contact Medtronic MiniMed
at 800-646-4633 (800-MINIMED), and select Option 1 for the 24-Hour Help Line.
For your convenience, you
may also contact us at www.minimed.com/QSP. We will ship replacement sets to
you free of charge and
arrange for return of your unused Paradigm Quick-set Plus sets to Medtronic
MiniMed for disposal.
You should discontinue use of Paradigm Quick-set Plus infusion sets as soon as
you have alternate sets
available. In the event that it is necessary to continue using Paradigm
Quick-set Plus infusions sets while
replacement sets are in transit, we recommend that you monitor your blood
glucose levels frequently. Be sure to
also check your blood glucose whenever you experience symptoms of high glucose
(i.e. fatigue, excessive thirst
or nausea) and be prepared to administer insulin by injection if necessary.
Please contact your healthcare
professional in the event of any excessively high or low glucose levels, or
with any questions about your care.
This product recall applies to all Paradigm Quick-Set Plus models (MMT-359S6,
359L6 and MMT-359L9) and lot numbers. We are taking this action based on the
high number of
complaints of elevated blood glucose levels received following launch of these
sets in November 2003.
Please note that only Paradigm Quick-set Plus infusion sets are being recalled.
Other infusion sets
distributed by Medtronic MiniMed (the Quick-set, Sof-set., Silhouette., etc.)
are not affected.
This letter is a follow-up to information we initially communicated to Paradigm
Quick-set Plus users in
March 2004. At that time, we provided additional recommendations for proper use
of the Paradigm
Quick-set Plus and the opportunity for customers to receive alternate sets.
Based on our ongoing
monitoring of complaints and discussions with the U.S. Food and Drug
Administration, we believe that
there is an unacceptable risk of interruption of insulin delivery associated
with use of the Paradigm
Quick-set Plus infusion sets. As a result, we are no longer distributing these
infusion sets and are
requesting that customers return any unused sets to us for disposal.
FDA regulations require that we confirm that all customers who have received
Paradigm Quick-set Plus
infusion sets have received this notification and have returned any unused set
to us. To help us with this effort,
please check the appropriate box on the enclosed, preaddressed, postage-paid
card (indicating whether
or not you have any unused Quick-set Plus infusion sets) and place in the
Please contact us at 800-646-4633 (800-MINIMED) or at www.minimed.com/QSP if
you have questions
regarding this recall or replacement of unused Paradigm Quick-set Plus infusion
sets. We thank you in advance
for your assistance and apologize for any inconvenience that you may experience
as a result of this situation.
Your Diabetes Care Team
) 2004 Medtronic MiniMed 9197054-011 5/04
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