Archived - Important Safety Information on Certain Blood Glucose Monitors - Abbott Diabetes Care

Subject: Abbott Provides Important Information Regarding Blood Glucose Monitor Units of Measure.

This letter is to inform you of an important subject regarding proper use of Abbott Diabetes Care blood glucose meters.

Abbott Diabetes Care meters are designed to show results in two different units of measure. This is dependent on country standards. In Canada, the correct unit of measurement is millimoles per liter or "mmol/L." In other countries the standard may be milligrams per deciliter or "mg/dL." If a user's meter is set up with the incorrect unit of measure they may have difficulty interpreting their result and this could lead to improper management of their diet or diabetes medication to control blood sugar levels. Currently, with Abbott Diabetes Care meters, the only way to change the "unit of measure" on meters is through a user-initiated change. Abbott Diabetes Care meters do not change units of measure when dropped or when there is a power failure.

Please review the following to confirm that you are using the correct unit of measure.

For FreeStyle^® and FreeStyle Mini™ Users:

1. Press the m button on the meter. The unit of measure will be shown on the display screen.
2. If the unit of measure is incorrect, it is important that you change it. Please refer to any of the following sources for detailed instruction:
   1. See user manual for meter set-up.
   2. Review the quick reference guide.
   3. Call customer care at 1-888-519-6890.

For Precision^® Xtra™ Users:

1. Turn on the meter and the unit of measure will appear on the result review display screen. Please confirm which Precision Xtra meter is being used.
2. If the unit of measure is incorrect, it is important that you change it. Please refer to any of the following sources for detailed instruction:
   1. See user manual for meter set-up.
   2. Review the quick reference guide.
   3. Call customer care at 1-888-519-6890.

In order to ensure that Abbott Diabetes Care customers will only receive results in their country's standard, Abbott Diabetes Care is proactively taking the following steps to minimize any chance of misinterpretation of results by the user.

1. Posted educational information regarding "Which Unit of Measure Does MY Country Use?" on the web site, AbbottDiabetesCare.com.
2. All future FreeStyle, FreeStyle Mini and Precision Xtra systems will be locked for the country standard in which they are shipped into.
3. Meter manual will be revised to reflect these changes.

We at Abbott Diabetes Care want to thank you for your continued support of our

FreeStyle^® and Precision^® Blood Glucose Systems. This notification is intended to ensure that you have the utmost confidence in the results your patients obtain. Should you have any questions, please contact Customer Care at 1-888-519-6890.

original signed by

Tina Mazurkiewicz

Divisional Vice President, Quality Assurance and Regulatory Affairs

Abbott Diabetes Care

Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with medical device treatments.

The identification, characterization, and management of medical device-related adverse incidents are dependent on the active participation of health care professionals in adverse incident reporting programmes. Any occurrences of adverse incidents or other serious and/or unexpected adverse incidents in patients using Abbott Diabetes Care blood glucose meters should be reported to Abbott Diabetes Care or Health Canada at the following addresses:

Abbott Diabetes Care

7115 Millcreek Drive

Mississauga, Ontario

L5N 3R3

Tel: 1-888-519-6890

http://www.abbottDiabetesCare.com

Any suspected adverse reaction 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

For other inquiries, please refer to contact information:

Marketed Health Products Directorate

mhpd_dpsc@hc-sc.gc.ca

Tel: (613) 954-6522

Fax: (613) 952-7738

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.