Wednesday, March 12, 2014
Health Canada
Abbott FreeStyle Glucose Test Strips May Produce False Test Results with Certain Devices
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.
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
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