Abbott FreeStyle Manuale operativo

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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 mbutton 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:

a. See user manual for meter set-up.

b. Review the quick reference guide.

c. Call customer care at 1-888-519-6890.

Units of

Measure

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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.

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 1-888-519-6890.

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.

Originally signed by,

Tina Mazurkiewicz

Divisional Vice President, Quality Assurance and Regulatory Affairs

Abbott Diabetes Care

Units of

Measure

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