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OneTouch SureStep Test Strips - Low Test Results when Blood Glucose is Greater than 22.2 mmol/L - For the Public
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(PDF Version - 47 K)Contact: Marketed Health Products Directorate
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This is duplicated text of a letter from LifeScan Canada Ltd.
Contact the company for a copy of any references, attachments or enclosures.
Public Communication
Health Canada Endorsed Important Safety Information on OneTouch SureStep Test Strips
March 18, 2010
Dear OneTouch® Customer:
Subject: OneTouch® SureStep® test strips may provide low test results when your blood glucose is greater than 22.2 mmol/L.
LifeScan Canada Ltd, in consultation with Health Canada, would like to inform you of important information regarding OneTouch® SureStep® test strips.
LifeScan has initiated a voluntary recall of specific lots of OneTouch® SureStep® Test Strips because they may provide low test results when your blood glucose is greater than 22.2 mmol/L. If you receive a meter reading that is greater than 22.2 mmol/L with these test strips, it is important that you confirm this result by another means because your actual blood glucose may be significantly higher. For example, if your blood glucose is greater than 22.2 mmol/L, retest your blood glucose using a meter other than OneTouch® SureStep® or contact your healthcare professional for further instructions.
Contact LifeScan Immediately To Find Out If Your Test Strips Are Affected
- To find out if your OneTouch® SureStep® Test Strips are affected, please call LifeScan's Customer Care Line at 1-866-339-3045, Monday to Friday, 6:00am-5:00pm PT (9:00am-8:00pm ET). Replacement product will be shipped to you immediately.
- While you wait for your replacement product to arrive, you should continue to test your blood glucose. However, if you use these affected strips and receive a result of 22.2 mmol/L or higher, there is a possibility that your blood glucose is significantly higher and you should confirm this result via another means or contact your healthcare professional.
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 adverse incidents for medical devices in patients using OneTouch® SureStep® Test Strips should be reported to LifeScan Canada or Health Canada at the following addresses:
#300 – 4170 Still Creek Drive,
Burnaby, BC V5C 6C6
1-866-339-3045
Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline 1-800-267-9675
The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web site.
For other medical device inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738
original signed by
Peter Menziuso
General Manager, LifeScan Canada Ltd.
