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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