Health Canada

Health Canada

June 20, 2013 17:30 ET

Potential of Under- or Over-Delivery of Insulin Associated with Paradigm and Polyfin Insulin Infusion Sets

OTTAWA, ONTARIO--(Marketwired - June 20, 2013) - Medtronic Canada Ltd., in consultation with Health Canada, is providing updated safety information regarding Paradigm and Polyfin Insulin Infusion Sets manufactured by Unomedical A/S and Medtronic Minimed due to a potential problem that could result in incorrect delivery of insulin to the patient.

As a result of problems associated with this device, Medtronic has received two incident reports regarding the under- or over-delivery of insulin. The under- or over-delivery of insulin may cause hypoglycaemia (low blood sugar) or hypoglycaemia (high blood sugar), and in extreme cases, may cause the loss of consciousness or death.

Medtronic Canada Ltd. is distributing a letter to patients currently using this product that will explain how to avoid the incorrect delivery problem. The company is also notifying all affected pharmacies and health care professionals in order for them to help concerned patients use this device.

Patients who are concerned about this device should contact Medtronic Canada Ltd.'s 24-hour product support line at 1-800-646-4633. Health Canada would also like to remind patients who have health concerns related to their use of this device to speak with their health care professional.

Medtronic has identified the following models as being affected:

Model Catalogue/ Refernce Number
PARADIGM SILHOUETTE INFUSION SETS MMT-379
MMT-380
MMT-377600
MMT-378600
MMT-381600
MMT-382600
MMT-368600
MMT-383600
MMT-384600
PARADIGM SURE-T INFUSION SET MMT-840
MMT-862
MMT-864
MMT-874
PARADIGM QUICK-SET INFUSION SETS MMT-396600
MMT-397600
MMT-398600
MMT-399600
MMT-386600
MMT-387600
MMT-394600
MINIMED PARADIGM SOF-SET ULTIMATE QR MMT-317
MMT-318
MMT-324
MMT-325
POLYFIN QR INFUSION SET MMT-312S
MMT-312L

How to report side effects to health products:

Complaints involving medical devices can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by writing to:

Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9

Également disponible en français.

Contact Information

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