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NOTIFICATION FOR "mg/dL" COUNTRIES
Urgent: Medical Device Correction

May 2005

If you use a OneTouch® Ultra™ or SmartScan™ Meter, we want to make you aware of two possible issues regarding these products.

1. Your meter is designed to show results in two different units of measure. When setting your meter's date and time, it is possible for you to accidentally change the unit of measure. You may misunderstand your blood glucose results if your meter is set to the wrong unit of measure. Your meter's unit of measure should be set to "mg/dL."

2. Very rarely, an event such as dropping your meter while in use can cause a brief power loss. As a result, the meter may unexpectedly change the unit of measure and/or the code number. Each time you test, make sure your meter's unit of measure is set to "mg/dL," and that the code number on the meter's display matches the code number on the test strip vial. This very rare power loss may also affect the meter's 14- and/or 30- day averages. If your averages are not what you expect, you should not rely on them.

mmol/LHow to Check Your Meter's Unit of Measure

Each time you turn on your meter, the unit of measure will appear on the display with the symbolsymbol. The unit of measure will also appear under every test result.

If your meter is set to the right unit of measure, "mg/dL" will appear on the display. Your test result will not include a decimal point (Fig. 1, OneTouch Ultra example). Do not change this setting - this is the right unit of measure for your country.

mg/dLIf your meter is set to the other unit of measure, "mmol/L" will appear on the display. The test result will include a decimal point (Fig. 2, OneTouch Ultra example). Unless your doctor has told you to use this unit of measure, do not test your blood glucose. Contact LifeScan immediately for assistance.

 

How to Check the Code Number

How to Check the Code NumberWhen you insert a strip, your meter will display a code number. Every time you test your blood sugar, compare the code number on the meter display with the code number on the test strip vial (Fig. 3, OneTouch Ultra example). If the two code numbers match, you may begin testing. If they do not match, please refer to your test strip insert or Owner's Booklet for instructions on how to calibrate the meter. If you need assistance, please contact LifeScan.

Always Check The Unit of Measure and Code Number Before Each Test

If you ever notice that:

  • your unit of measure or 14- and/or 30-day averages are not what you expect, or
  • your code number has unexpectedly changed,

contact LifeScan for immediate assistance.

How to Contact LifeScan
Toll Free Line: 1 800 1 888-7954
Direct Line: (63+2) 824-8736
OneTouch Txt World SMS: 0917-5355567
E-mail: Service@OneTouchAsia.com

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1-800-1-888-7954
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e-Mail: Service@OneTouchAsia.com

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