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Urgent Medical Device Correction: Labeling Change for the OneTouch® UltraSmart® Meter

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A Letter To LifeScan Customers:

URGENT: MEDICAL DEVICE CORRECTION

Labeling Change for the OneTouch® UltraSmart® Meter

June 9, 2005

If you use, recommend, distribute or sell the OneTouch® UltraSmart® Meter, we want to make you aware of two discrepancies in the meter's instructional materials.

1. When Users Should Expect The Message, "Do You Need A Snack?"
There is a difference between how a specific feature of the meter operates and how it is described in the Owner's Booklet and Quick Reference Guide.

With test results from 20 through 59 mg/dL, Fig 1, (1.1 through 3.3 mmol/L, Fig 2) the meter is designed to display the message "Do you need a snack?" beneath the blood glucose test result.

However, the Owner's Booklet and Quick Reference Guide state that this message will appear when blood glucose results are between 20 and 70 mg/dL (1.1 and 3.9 mmol/L).

This updated information on the "snack" message has no impact on the accuracy of test results, and users can continue to test their blood glucose with the OneTouch UltraSmart Meter. The meter is performing correctly when it displays the "Do you need a snack?" message at blood glucose levels from 20 through 59 mg/dL (1.1 through 3.3 mmol/L).

Patients should contact their healthcare professional if they have questions regarding the appropriate treatment for blood glucose results below their target range.

2. Patients Should Perform Arm Testing On The Forearm Only
The OneTouch UltraSmart Owner's Booklet also provides instructions on how to perform arm testing.* In the section "Arm Blood Sampling," the step "Choose the Puncture Site" shows a diagram highlighting two parts of the arm-the upper arm and the forearm-suggesting that both areas may be used for arm testing (Fig. 3).

The diagram and the instructions are being updated so that only the forearm is highlighted (Fig. 4). Patients can continue to use the OneTouch UltraSmart Meter and OneTouch Ultra Test Strips for arm testing, as long as they test only on the forearm.

Users Should Continue Testing With The OneTouch UltraSmart Meter
We recommend that OneTouch UltraSmart Meter users print this notice and kept it with their meter's instructional materials for future reference. If you have questions about this notice or the OneTouch UltraSmart Meter, please contact LifeScan.

How To Contact LifeScan

People with diabetes
Telephone: U.S. 866 461-0094, For all other countries, see Around the World.)

E-mail: CustomerService@LifeScan.com

Healthcare Professionals
Telephone: U.S. 866 461-0043, For all other countries, see Around the World.)

Retailers/Distributors:
Telephone: U.S. 800 600-7226, For all other countries, see Around the World.)


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