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A Letter To LifeScan Customers:
--URGENT PRODUCT NOTIFICATION ABOUT OneTouch® PROFILE® METERS--

If you use a OneTouch® Profile® Blood Glucose Meter (intended for use with OneTouch® Brand Test Strips) to test your blood glucose, recommend it to your patients, or distribute and sell it to customers, please take a few moments to read this important announcement.

OneTouch ProfileSome OneTouch Profile Meters May Develop Display Problems

The OneTouch Profile Meter has a display that presents test results and other important information. The display is made up of a series of "segments" that are turned on and off in various combinations to form letters and numbers.

Any meter's display, as it ages, may begin to show signs of failure. This can cause certain letters or numbers to appear as incomplete. If the meter's display begins to fail, there is a possibility that it will present a test result or a calibration code that could be misinterpreted or is unrecognizable. It is therefore extremely important that you check your display each time you test your blood.

We have recently determined that OneTouch Profile Meters exhibit a higher-than-expected number of display problems as they age. While this may occur at any time, this tends to peak two-and-a-half years after the meter was manufactured. We want to call your attention to this potential problem so that you can determine if your meter's display is working properly, and to offer a replacement meter if needed.

How To Check The OneTouch Profile Meter's Display A display test is already built into your meter. When you first begin to perform a blood or control solution test, the entire display will briefly turn on when you turn on your meter. You should carefully observe the display to make sure all "segments" or parts of the display turn on each time you test your blood (see illustrations below). If this test does not last long enough for you to carefully observe it, you can press and hold the "power" button of your meter. This will activate all working segments in the display for a few seconds. Compare the active segments in your meter's display with the diagrams below. Similar diagrams can also be found in your OneTouch Profile Meter Owner's Booklet. If you need more time, press the power button again to turn off the meter and repeat the process by pressing and holding the power button. As an additional check, you can also watch your meter's countdown from 45 seconds to 0 to verify that the numbers are displayed correctly.

DISPLAY TEST

DISPLAY TEST

TEST RESULT

Properly Functioning Display

Display with Missing Segments

Recognizable Result, but Incorrect

Test Result
Test Result
Test Result

All segments are active,the display is working properly.

 

Some parts of the display are not working. Message will beincomplete.

 

In this example, the 120 resultis really 420, as indicated by the missing segments shown in gray.


Contact LifeScan If You Detect A Display Problem

If you believe your OneTouch Profile Meter's display has a problem, or if you need help determining if your display is operating properly, contact LifeScan for assistance.

If your OneTouch Profile Meter's display is functioning properly, you should continue to use your meter and OneTouch Brand Test Strips with confidence. However, because the chances of a display problem increase as your meter gets older, we urge you to observe the display test at the beginning of every blood test to verify the continued performance of your system. If at any time your meter develops a display problem, please contact LifeScan for a replacement as described below. Print out and attach this notice to your Owner's Booklet as a reminder to check your meter's display.

How LifeScan Is Addressing This Issue

Upon request, LifeScan will replace free of charge all OneTouch Profile Meters that have display problems with a new or equivalent meter. A customer notification program is being implemented in all countries where the OneTouch Profile Meter is sold. In the United States, LifeScan is taking the following actions to contact OneTouch Profile Meter users:

1. A notification letter is being sent to all registered OneTouch Profile Meter owners. This letter describes the problem and provides detailed information to help a person determine if their OneTouch Profile Meter's display is working properly.

2. A similar notice will soon be placed in all OneTouch® Basic®/PROFILE®/OneTouch® II Blood Glucose Test Strip packages.

3. LifeScan is sending a letter to pharmacists throughout the U.S. advising them of this issue and asking for their support in disseminating this information to all their OneTouch Profile Meter customers. Similar letters are being sent to a group of healthcare professionals. OneTouch Profile Meter users with questions about this issue will be referred to LifeScan's 24-hour Customer Care Line for assistance.

How To Contact LifeScan

At LifeScan, we know our customers rely on our products to help them manage their diabetes. It's a responsibility we take very seriously. If you need to contact LifeScan regarding this issue please contact us in one of the following ways:


People with diabetes
Telephone: U.S. 1 877 785-3456; Canada 1 888 233-6622; Mexico 95 1 800 381-SCAN; for other countries, see Around the World.

Healthcare Professionals
Telephone: U.S. 800 524-7226, for other countries, see Around the World.

Retailers/Distributors:
Telephone: 800 600-7226, for other countries, see Around the World.

Thank you for your continued support of LifeScan.


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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.