OTTAWA, ONTARIO--(Marketwired - March 11, 2014) - Health Canada is informing Canadians that when Abbott FreeStyle glucose test strips are used with the devices listed below, there is a potential for users to receive a lower-than-actual blood sugar reading.
False low blood sugar readings may lead to improper treatment decisions for users, such as increasing the consumption of sugar or not taking enough insulin, which in turn could lead to hyperglycemia (elevated blood sugar levels).
The three devices are: Abbott Diabetes Care's FreeStyle Blood Glucose Meter and FreeStyle Mini Blood Glucose Meter, and Insulet's OmniPod Insulin Management System.
Consumers with the affected FreeStyle meters should contact Abbott Diabetes Care at 1-877-576-9368.
Consumers with the Insulet OmniPod Insulin Management System should contact Abbott Diabetes Care at 1-877-607-6364 regarding the Freestyle strips, or if they have questions about the use of the system they should contact Insulet at 1-855-763-4636.
The two companies are notifying customers to inform them of this issue.
Consumers who have concerns related to the use of these devices should speak with their health care professional.
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
|Address Locator: 2003D
|Ottawa, Ontario K1A 0K9
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