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Important Safety Information on Abbott Diabetes Care Precision Xtra - For Health Professionals
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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.
This is duplicated text of a letter from Abbott Diabetes Care.
Contact the company for a copy of any references, attachments or enclosures.
September 12, 2007
Subject: Abbott Diabetes Care Precision XtraTM Product Notification
Dear Health Care Professional,
At Abbott Diabetes Care, the quality of patient care is our priority. We want to make you aware of a situation that could possibly affect patients using the Precision XtraTM blood glucose monitor.
We have found that Precision XtraTM monitors distributed between May 2007 and August 2007 may experience damaged displays when dropped onto a hard surface. Part of the display can be jarred and disconnected, making it difficult to read the lot number or date information as noted below. The display may also appear mostly blank. As with all product-related situations, we are taking this seriously and are actively working to ensure that you and your patients are well informed, and the products we supply are meeting our quality standards. To date, there are no reports of damage affecting the readings on the monitor.
What Can You Do To Help?
We are recommending that patients keep their monitor in the wallet that is provided, as this provides protection against accidental falls. We also want to reinforce the importance of performing a Display Check as recommended in the first section of the User Guide: "Important Information - Getting to Know Your Monitor's Features" section. If the monitor display does not match the picture exactly, the monitor should not be used.
Please contact our Customer Care Centre at 1-888-519-6890 if you have questions, or need to replace a damaged monitor.
Abbott Diabetes Care
7115 Millcreek Drive
Mississauga, ON
L5N 3R3 Canada
1-888-519-6890
Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Tel: 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 inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: mhpd_dpsc@hc-sc.gc.ca
Tel.: 613-954-6522
Fax: 613-952-7738
Sincerely,
original signed by
Mark Tatro
General Manager, Abbott Diabetes Care Canada
