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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