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.
How
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 symbol.
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.
If
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
When
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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