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 hypoglycemia (low blood sugar) or hyperglycemia (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/ Reference Number Paradigm Silhouette Infusion Sets MMT-379 MMT-380 MMT-377600 MMT-378600 MMT-381600 MMT-382600 MMT-368600 MMT-383600 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
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