Abbott Diabetes Care 7115 User Manual

Abbott Diabetes Care
7115 Millcreek Drive
Mississauga, Ontario L5N 3R3
www.abbottDiabetesCare.com

September 16, 2005

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.

:

.

Units of
Measure

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:

a. See user manual for meter set-up.
b. Review the quick reference guide.
c. Call customer care at 1-88 8-519-6890.

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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.

Units of
Measure

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

a. See user manual for meter set-up.
b. Review the quick reference guide.
c. Call customer care at 1-88 8-519-6890.

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.

Originally signed by,
Tina Mazurkiewicz

Divisional Vice President, Quality Assurance and Regulatory Affairs
Abbott Diabetes Care

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