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

(firmenpresse) - OTTAWA, ONTARIO -- (Marketwired) -- 06/20/13 -- 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:

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:

Egalement disponible en francais.



Contacts:
Media Inquiries:
Health Canada
613-957-2983

Public Inquiries:
613-957-2991
1-866-225-0709

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Bereitgestellt von Benutzer: Marketwired
Datum: 20.06.2013 - 21:30 Uhr
Sprache: Deutsch
News-ID 271952
Anzahl Zeichen: 0

contact information:
Town:

OTTAWA, ONTARIO

Kategorie:

Government & Administration

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