Critical Safety Information/Important Information/Limitations/Expected Results - McKesson TRUEresult Owner's Manual

TRUEresult Quality Assurance / Quality Control Manual
®
Critical Safety Information / Important Information / Limitations /
Expected Results
WARNING!
TRUEtest Blood Glucose Test Strips utilize glucose dehydrogenase-PQQ
(GDH-PQQ). The TRUEresult System MUST NOT be used for the following
patient conditions:
• Peritoneal dialysis patients receiving dialysis solutions containing
icodextrin (e.g. Extraneal
maltose,
• Injection or infusion of solutions containing galactose or maltose,
including some human immunoglobulin preparations
(e.g. Octagam
• Patients undergoing xylose absorption testing,
• Patients receiving intravenous solutions containing maltose as a
substitute for glucose or as a means for patient hydration,.
• Any drugs, including any investigational drugs and those made by
compounding pharmacies, which contain or metabolize to maltose,
galactose, or xylose (Orencia
Using the TRUEresult System for testing patients with the above conditions
may result in falsely high glucose results. A falsely elevated glucose result may
cause a patient or healthcare professional to take inappropriate steps to bring
the blood glucose in normal range, including giving insulin. The inappropriate
use of insulin could lead to unconsciousness, severe hypoglycemic coma and
possible death. More information may be found in the TRUEtest Test Strip
Instructions for Use or at
www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm154213.htm
Limitations
• Please read all product Instructions for Use carefully before
referencing or using this Manual.
• Use only TRUEtest Blood Glucose Test Strips and TRUEtest Glucose
Control Solution when testing with the TRUEresult Meter.
Perform Glucose Control Tests before performing a blood glucose
•
test (See Quality Control Testing, Section 3), when using the System
for the first time. Three levels of TRUEtest Glucose Control Solution
are available for Quality Control Testing. Contact your distributor to
order different levels of Glucose Control Solution. We recommend
testing at least 2 levels of Control. For testing frequency and the
number of Control levels to test, refer to your facility quality control
procedure/policy.
TRUEresult is an in vitro quantitative system that is used for self
•
testing and point-of-care testing of human whole blood only.
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