SECTION
A
6
WARNINGS AND PRECAUTIONS
• For
in vitro
Diagnostic Use.
• Never make significant changes to your diabetes control program or ignore physical
symptoms without consulting with your healthcare professional.
• Severe dehydration (excessive water loss) may cause false low results. If you believe
you are suffering from dehydration, consult your healthcare professional immediately.
• Extremes in hematocrit may affect test results. Hematocrit levels less than 30%
may cause falsely high readings. Hematocrit levels greater than 55% may cause
falsely low readings.
• Inaccurate results may occur in severely hypotensive individuals or patients in shock.
• Inaccurate low results may occur for individuals experiencing a hyperglycemic/
hyperosmolar state, with or without ketosis.
• Critically ill patients should not be tested with blood glucose meters.
• Patients undergoing oxygen therapy may yield false results.
• High levels of ascorbic acid may yield inaccurate results.
• Externally taken drug ephedrine will not interfere with blood glucose results when
taken at therapeutic concentrations. However, abnormally high concentrations in blood
may cause inaccurate results.
Healthcare Professionals: Please note additional limitations of procedure:
• Triglycerides at 3,300 mg/dL may significantly affect test results.
• Metabolites of icodextrin (maltose, maltotriose and maltotetraose) do not significantly
affect test results.
Limitations of System
• The Assure Platinum Blood Glucose Monitoring System is not designed to substitute
pathology laboratory equipment and should not be used for the diagnosis of diabetes.
• Use only fresh capillary whole blood. Do not use serum or plasma or venous whole blood.
• Do not use the Assure Platinum Blood Glucose Monitoring System to test neonates.
It has not been validated for neonatal use.
• Assure Platinum Test Strips may be used at altitudes up to 10,000 ft (3,048 m) without
effect.