Important Safety Information on Medtronic Paradigm Quick-set Infusion Sets (Models MMT-396, MMT-397, MMT-398 and MMT-399) - Notice to Hospitals

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Contact: Marketed Health Products Directorate (MHPD)

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

Notice to Hospitals
Health Canada Issued Important Safety Information on Medtronic Paradigm Quick-set Infusion Sets

August 5, 2009

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Pharmacy and Endocrinology, Diabetic Education Units, other Departments as required, and other involved professional staff. Please also post this Notice in your institution.

Subject: Medtronic Paradigm Quick-set Infusion Sets - Recall on lot 8 (Models MMT-396, MMT-397, MMT-398 and MMT-399)

Medtronic of Canada is recalling Paradigm Quick-set infusion sets that have lot numbers starting with the number "8". These infusion sets are intended for the subcutaneous infusion of insulin from Medtronic MiniMed Paradigm insulin infusion pumps. "lot 8" Quick-set infusion sets were primarily manufactured for distribution in the United States, but limited quantities of these sets were also distributed in Canada by various distributors. No other lots or infusion sets are affected by this recall.

It has been identified that a small percentage of Quick-set infusion sets in the affected lots may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the reservoir compartment with the surrounding atmosphere. If the vent does not work properly, this could potentially result in too much or too little insulin being delivered and may lead to serious health consequences. The venting issue has since been corrected.

Healthcare professionals should be aware of the following information:

If you have any questions or concerns that have not been fully addressed in this letter, please call the Medtronic Customer Service line at 1-800-284-4416 between 8:30 a.m. and 7:00 p.m. EST.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious incidents related to Paradigm Quick-set infusion sets or other serious or unexpected adverse incidents for medical devices in patients using Medtronic MiniMed Paradigm insulin pump systems should be reported to Medtronic of Canada or Health Canada at the following addresses: