News Flash:

IMPORTANT NEW TROUBLESHOOTING INFORMATION REGARDING THE OPERATION OF ONE TOUCH® ULTRA & INDUO™ METERS –

If you use a ONE TOUCH Ultra® Blood Glucose Meter or InDuo™ System, or you recommend either of these products to diabetes patients, please take a few moments to read the following important information describing two conditions that could potentially affect the operation of these meters.

1. Condition #1: An "Er 4" display message may mean a high glucose level when testing in a low temperature environment.

2. Condition #2: Brief power loss may cause the meter to enter set-up mode and may indicate a possible meter memory problem


Condition #1: An "Er 4" display message may mean a high glucose level when testing in a low temperature environment.

Generally, Er 4 messages on the ONE TOUCH Ultra and InDuo Systems are related to problems with the test strip being damaged, inserted improperly, or moved during a test. LifeScan has recently determined that another combination of factors will also cause an Er 4 message. A blood glucose test performed in an environment near the low end of these systems' operating temperature range (43-111°F/6-44°C) may result in an Er 4 message if the blood glucose value is high.

What You Should Do:

If a test has been performed in a cool environment and the meter displays an Er 4 message, the test should be repeated in a warmer environment-preferably indoors-with a new test strip. If the error message appears again, contact 877-520-8590. To ensure accurate results, the meter will not produce a test result when the temperature is above 111°F (44°C) or below 43°F (6°C). Any blood glucose results received when testing within the meter's operating temperature range should be considered accurate.

Condition #2: Brief power loss may cause the meter to enter set-up mode and may indicate a possible meter memory problem

Whenever the meter loses power for any reason it will enter the set-up mode. This is indicated by the fact that the next time the meter is turned on, the time (for example, 12:00 AM ) will be flashing on the display.

What You Should Do:

If the meter experiences a power loss, reset the time, time format, date, and most importantly, the unit of measure (mg/dL or mmol/L). See pages 34-38 of the ONE TOUCH Ultra Owner's Booklet or pages 5-9 of the InDuo Owner's Booklet for information on the meter settings.

If, after resetting the meter and inserting a test strip, three dashes (- - -) appear on the display, the code number has been lost and the code must be reset on the meter. The three-dashes display (- - -) also means that the test results stored in the memory may not be in the order in which they were performed. Therefore, do not rely on the 14- and 30-day averages or transfer the data from the meter to a computer using IN TOUCH® Software, as the data may not be presented correctly in IN TOUCH.

Whatever the case, if the meter displays three-dashes after being reset and a strip has been inserted, there may be a problem with the meter, and it is important to call LifeScan Customer Services at 877 520-8590.

How LifeScan is Addressing This Issue
LifeScan is implementing a corrective action plan in all countries where the ONE TOUCH Ultra and InDuo Systems are sold. In the United States, LifeScan is taking the following actions to address this issue:

1) Beginning in May 2002, an updated Quick Reference Guide and an addendum to the ONE TOUCH Ultra and InDuo Owner's Booklets will be mailed to healthcare professionals and all registered users of these products for future reference. These materials explain the two issues further and what actions to take if users of these products experience either issue.

2) The updated Quick Reference Guide and the addendum to the ONE TOUCH Ultra Owner's Booklet have been posted on the ONE TOUCH Ultra and IN TOUCH product pages on www.LifeScan.com. The Quick Reference Guide and the addendum to the InDuo Owner's Booklet have been posted on www.InDuo.com.

U.S. Residents: The mailing of ONE TOUCH Ultra and InDuo materials noted above will begin in May 2002 and will take a few weeks to complete. If you do not receive an updated Quick Reference Guide and an Owner's Booklet addendum for either the ONE TOUCH Ultra or InDuo System by July 1, 2002, and you would like to receive these materials in the mail, please call our toll-free, 24-hour Customer Care Line at 877 520-8590.

How To Contact LifeScan
If you need to contact LifeScan regarding this or any other issue, please contact us in one of the following ways:

  • People with diabetes
    Telephone: U.S. 800 520-8590; Canada 888 233-6622; Mexico 95 800 381-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: U.S. 800 600-7226, for other countries, see Around the World.)

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