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Letter To OneTouch® Ultra® Customers In The U.S.:
-- Important Instructional Information: Updated OneTouch® Ultra® Owner’s Booklet --

February 4, 2004

If you use a OneTouch® Ultra® Blood Glucose Meter to test your glucose, have patients who use it, or distribute and sell OneTouch Ultra Meters to customers, please read the following important information regarding OneTouch Ultra Meters distributed in the United States.

We have recently determined that OneTouch Ultra Owner's Booklets provided in system kits shipped in the U.S. between June 2003 and December 2003 do not contain important information describing the two different units of measure that can be displayed with test results and how to set the units of measure.

The OneTouch Ultra Blood Glucose Monitoring System (meter) can display results in two different units of measure. "Milligrams per deciliter" (mg/dL) is the standard unit in the United States. Because people living in other parts of the world may purchase this meter, it may also be reset to another unit of measure called "Millimoles per liter" (mmol/L). This unit is not used in the United States. (Refer to your Owner's Booklet for more information.)

To confirm that the OneTouch Ultra Meter is correctly set to "Milligrams per deciliter" (mg/dL), simply turn on the meter. The "mg/dL" unit of measure should appear on the display with the "apply blood" symbol. Also, when looking at a test result on the display, "mg/dL" will appear with the result. If, however, you see "mmol/L" displayed, or the test result includes a decimal point, the meter is incorrectly set to "Millimoles per liter" and should be changed to "mg/dL" unless specifically recommended by a doctor. (Refer to your Owner's Booklet for more information and on how to leave the Set-Up mode.)

To correct this printing error, we have sent updated Owner's Booklets to all registered OneTouch Ultra Meter users in the U.S. that are affected by this issue. However, not all persons register their meter with LifeScan. Customers in the United States, who have not already received one, can download the updated OneTouch Ultra Meter Owner's Booklet or request one by mail by calling our 24-hour LifeScan Customer Care line at 877 903-2132.

Please be assured that this correction to the OneTouch Ultra Owner's Booklet has no impact on the reliability of the meter or the accuracy of its test results.

 


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The health information on this Web site is for general background purposes and is not a substitute for medical advice or treatment for specific conditions. Seek prompt medical attention for health care questions you have. Consult your physician before making changes to your medication, diet, fitness program, or blood glucose testing schedules.