URGENT Medical Device Recall Notice Used With Paradigm

URGENT Medical Device Recall Notice Used With Paradigm
Medtronic, Inc.
18000 Devonshire St.
Northridge, CA 91325
www.medtronicdiabetes.com
tel 1.800.646.4633
July 3, 2013
URGENT Medical Device Recall Notice
Recall of Certain Lots of MMT-326A and MMT-332A Reservoirs
Used With Paradigm® Insulin Pumps
Dear Valued Medtronic Customer:
Because the safety of our customers is our top priority, we are voluntarily recalling certain
manufacturing lots of model MMT-326A (1.8 mL) and MMT-332A (3.0 mL) reservoirs used with
our Paradigm insulin pumps. We are recalling these reservoirs due to the potential that
reservoirs from these lots may be at increased risk 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.
Our investigation has indicated that this increased potential for reservoir leakage was caused by
abnormal wear on a manufacturing tool involved in the production of reservoir stoppers. We are
recalling all lots of reservoirs that contain any stoppers from that tool. We have corrected this
problem and have placed additional testing and inspection steps into our manufacturing
process.
Affected Reservoir Lot Numbers
Our records indicate that Medtronic has NOT shipped you any reservoirs from the affected lot
numbers. However, if you obtain your reservoirs from a mail order supplier, distributor,
pharmacy, your doctor’s office, or anywhere else, you will need to follow the actions below to
determine if you have affected lots.
Required Actions
1.
Check your reservoir lot numbers to see if they are on the recall list:
o Use our online tool at www.medtronicdiabetes.com/checklots; or
o Refer to the recall list in the attached Q&A
2.
Don’t use reservoirs from the recalled lots.
3A. If you only have reservoirs from affected lot numbers:
o Switch to your back-up insulin injection plan according to the direction of your
healthcare professional.
o Call us to expedite a replacement box at 1.866.450.0890.
3B. If you have a combination of supply from both affected and unaffected lot numbers, let
us know your replacement needs using one of the following methods:
o Online form at www.medtronicdiabetes.com/support/product-updates (fastest
method)
o Mail the enclosed reply card
3C. If you do not require replacement reservoirs, check the appropriate box on the reply
card and drop it in the mail.
4.
Dispose of your affected reservoirs (they do not need to be returned). Please
remember to follow your local governmental regulations for disposal of sharps.
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Please know that we will replace all reservoirs that you have from the affected lots at no cost to
you, and will make this process as easy as possible. A list of frequently asked questions is
included with this letter and posted on our website at
www.medtronicdiabetes.com/support/product-updates.
Risk to Health
Under-delivery of insulin can cause high blood sugar, which if untreated can lead to
diabetic ketoacidosis (DKA). DKA is a serious condition that can cause a severe impact
to health, including death. Symptoms of diabetic ketoacidosis may include nausea,
vomiting, shortness of breath and excess thirst/urination. Seek medical attention
immediately if you are experiencing any of these symptoms.
In most cases, the impact of a leaking reservoir is limited to a temporary increase in glucose
levels. We have received a small number of reports of patients being hospitalized for diabetic
ketoacidosis which may be a result of insulin under-delivery due to the reservoir leaking.
Adverse reactions or quality problems experienced with the use of Medtronic Diabetes insulin
pumps, infusion sets or reservoirs may be reported to the FDA’s MedWatch Adverse Event
Reporting program:
Online at: http//www.fda.gov/safety/medwatch/howtoreport/default.htm
Report by telephone: 1.800.FDA.1088
Fax report: 1.800.FDA.0178
At Medtronic, making quality products that you can trust is our top priority. We are committed to
improving our products and to communicating about potential issues when they arise. We will
continue to communicate as often as needed because we know that is what you expect from
Medtronic as your partner in diabetes care. We believe doing so makes our customers the
safest, most educated and informed patients.
For more information:
Visit our website at www.medtronicdiabetes.com/support/product-updates or
Call for replacements at 1.866.450.0890 Monday through Friday, 8 AM – 6 PM Central
Time. If you have an urgent issue, our 24-Hour HelpLine is always available.
We appreciate your time and attention to this important notification.
Sincerely,
Shirajul Karim
Vice President, Quality
Medtronic Diabetes
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930M11468-011 20130628 @2013 Medtronic MiniMed, Inc. All rights reserved.
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