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Potential of under- or over-delivery of insulin associated with Paradigm and Polyfin Insulin Infusion Sets
- Starting date:
- June 20, 2013
- Posting date:
- June 20, 2013
- Type of communication:
- Information Update
- Subcategory:
- Medical Device
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public
- Identification number:
- RA-34261
Issue
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.
| 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 |
What you should do
- 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.
Report health or safety concerns
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
Media enquiries
Health Canada
(613) 957-2983
Public enquiries
(613) 957-2991
1-866 225-0709