TRUE METRIX
®
PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Limitations of Use 14
Limitations of Use
• Please read all product Instructions for Use
carefully before referencing or using this guide.
• Use only TRUE METRIX
®
PRO Blood Glucose Test
Strips and TRUE METRIX
®
Control Solution with
the TRUE METRIX
®
PRO Meter.
• Do not leave test strips or control solution where
the storage temperature printed on vial label may
be exceeded.
• Perform control tests before performing a blood
glucose test for the first time (See the Quality
Control Testing section of this Resource Guide).
• Perform control tests with more than one level of
control solution. Three levels of TRUE METRIX
®
Control Solution are available for control tests.
Contact place of purchase or call for assistance to
obtain control procedure/policy.
• TRUE METRIX
®
PRO is an in vitro (outside the
body) quantitative system that is used for multiple-
patient use testing of human whole blood only.
• The most accurate results are obtained using
fresh, capillary whole blood from the fingertip or
forearm. Venous whole blood drawn using only
sodium heparin tubes may be used. Mix well before
use.
• Do not use venous whole blood collected in sodium
fluoride (grey top) vacutainer tubes for testing, as
this may cause false low results.
• Capillary blood from the forearm may be used.
Check with the doctor or healthcare professional
to see if forearm testing may be used for glucose
testing on the patient. Results from the forearm
are not always the same as results from the
fingertip. Use fingertip instead of forearm:
5
- Within 2 hours of eating, exercise, or
taking insulin;
- If the patient’s blood glucose may be rising or
falling rapidly or their results often fluctuate;
- If the patient is ill or under stress;
- If the glucose result may be low or high;
- If symptoms of low or high glucose levels are
not evident.
• Alternate site (forearm) testing should not be used
to calibrate continuous glucose monitors (CGMs).
• Alternate site (forearm) testing should not be used
for insulin dose calculations.
• Do not use for the diagnosis of or screening for
diabetes mellitus or for measuring blood glucose
in newborns.
• When comparing results between TRUE METRIX
®
PRO and a laboratory system, TRUE METRIX
®
PRO blood tests should be performed within 30
minutes of laboratory test. If a patient has recently
eaten, fingerstick results from the TRUE METRIX
®
PRO System can be up to 70 mg/dL higher than
venous laboratory results.
5
Diabetes experts have
suggested that glucose meters should agree within
15 mg/dL of a laboratory system when the glucose
concentration is less than 75 mg/dL, and within
20% of a laboratory system when the glucose
concentration is 75 mg/dL or higher.
3
• The device has not been validated for use in the
critically ill. Capillary blood glucose levels in
critically ill patients with reduced peripheral blood
flow may not reflect the true physiological state.
Reduced peripheral blood flow may result from the
following conditions (for example):
7
- shock,
- severe hypotension,
- severe dehydration,
- hyperglycemia with hyperosmolarity, with or
without ketosis.
• Testing at altitudes up to and including 10,200 feet
will not affect accurate results.
4
• Hematocrit levels between 20% and 70% will not
affect accurate results.
4
• Do not use the TRUE METRIX
®
PRO System
during a xylose absorption test. This may falsely
raise glucose results. Please check with patients
doctor before using the TRUE METRIX
®
PRO
System.
• Do not use the TRUE METRIX
®
PRO System if
blood concentrations of ascorbic acid are
> 2 mg/dL
• Do not use the TRUE METRIX
®
PRO System if blood
concentrations of uric acid > 5 mg/dL
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