Urgent Medical Device Safety Notification

Urgent Medical Device Safety Notification
Medtronic, Inc.
18000 Devonshire St.
Northridge, CA 91325
www.medtronicdiabetes.com
tel 1.888.204.7616
Urgent Medical Device Safety Notification
Potential for Over or Under Delivery of Insulin if Insulin or Other Fluids Contact the
Inside of Medtronic Paradigm Infusion Set Connectors
June 10, 2013
Dear Paradigm® Insulin Pump User:
The purpose of this letter is to notify you that Medtronic Diabetes has become aware of a
potential safety issue that can occur if insulin or other fluids come in contact with the inside of
the connector on Medtronic Paradigm infusion sets. This letter also provides information that
will allow you to prevent this from occurring.
Exposure of the inside of the infusion set connector to fluid is most likely to occur if insulin is
spilled on the top of the insulin reservoir when the reservoir is removed from the transfer guard
after filling the reservoir from a vial of insulin. If this occurs, the insulin can temporarily block
the vents in the connector that allow the pump to properly prime. If these vents are blocked,
this can potentially result in too much or too little insulin being delivered, which may cause
hypoglycemia or hyperglycemia, which, in extreme cases, may cause loss of consciousness or
death.
The information in this letter applies to all Medtronic infusion sets designed for use with
Medtronic Paradigm family infusion pumps. The specific model numbers affected are listed at
the end of this letter. Please note that the potential for temporary blocking of the infusion set
vents can be avoided by not applying liquid to the inside of the infusion set connector and
following the recommended reservoir filling procedure with careful attention to the information
provided below.
To prevent fluid from blocking the connector vents:
1. After filling the reservoir, make sure the vial of insulin is held upright when removing the
reservoir from the blue transfer guard. This prevents insulin from accidentally getting on
the top of the reservoir, which could transfer liquid into the tubing connector.
Vial
upright
Hold insulin vial upright when removing reservoir.
940M11325-011 20130506. © 2013 Medtronic MiniMed, Inc. Paradigm is a registered trademark of Medtronic MiniMed Inc. All rights reserved.
2. If any liquid (such as insulin, isopropyl alcohol, or water) gets on the top of the reservoir or
inside the tubing connector, start over with a new reservoir and infusion set.
Top of reservoir
Tubing
connector
Make sure these are dry when connecting.
How to recognize that the infusion set vents may be blocked
If you notice anything unusual during the infusion set prime process such as the insulin
continuing to drip from the infusion set cannula when priming has been completed, this may
indicate that the connector vents are not working properly. If this occurs, do not insert the
infusion set and call the HelpLine immediately for additional assistance.
In addition to providing this communication to current users of Medtronic Paradigm insulin
pumps, we are also updating the instructions for use to include this information on how to avoid
temporary blocking of the infusion set vent membranes due to exposure to fluid.
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 either online, by regular mail or by fax.
We have notified your healthcare professional about this potential safety issue and are here to
assist you with any questions or concerns you may have. Please feel free to visit our website at
http://www.medtronicdiabetes.com/support/product-updates or contact our 24-Hour Helpline at
888.204.7616 if you would like more information. We appreciate your time and attention to
this important notification and your continued trust in Medtronic.
Sincerely,
Shirajul Karim
Vice President, Quality
Medtronic Diabetes
940M11325-011 20130506. © 2013 Medtronic MiniMed, Inc. Paradigm is a registered trademark of Medtronic MiniMed Inc. All rights reserved.
*This field notification involves models MMT-317, MMT-318, MMT-324, MMT-325, MMT-312S, MMT-312L, MMT-386, MMT-387,
MMT-394, MMT-396, MMT-397, MMT-398, MMT-399, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384, MMT-368,
MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, MMT-886, MMT-921, MMT-923, MMT-925, MMT-941, MMT-943,
MMT-945, MMT-961, MMT-963, MMT-965, & MMT-975 Paradigm infusion sets.
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