- Users should wash their hands thoroughly with soap and water before and after handling the
meter, lancing device, or test strips.
Please see the following references for further information.
1."FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for
Transmitting Bloodborne Pathogens: Initial Communication" (2010)
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
2."CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk or
Transmitting Bloodborne Pathogens" (2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
Limitations
- Blood glucose meter readings may be significantly lower than "true glucose levels" in a
hyperglycemic- hyperosmolar state, with or without ketosis.
- Caution is advised when glucose values are below 50 mg/dL or above 250 mg/dL. Consult a
Physician as soon as possible, if values in this range are obtained.
- Healthcare professionals should evaluate their patients' technique regarding the use of the
iGlucose Blood Glucose Monitoring System regularly. To accomplish this, it is recommended that
blood glucose monitoring results be compared with a concurrently obtained laboratory
measurement on the same blood sample. A proven clinical laboratory method employing hexokinase
or glucose oxidase should be used as the comparative method.
- Hands and fingers contaminated with sugar from foods or beverages may cause falsely elevated
results.
- The results of blood glucose measurements are different for measurements with whole blood and
plasma.
- Storage of strips near bleach as well as bleach containing products will affect the results of the
iGlucose Blood Glucose Test Strips.
- Inaccurate test results may be obtained at altitudes greater than 10,000 feet (3,048 meters) above
sea level.
- Hematocrits below 20% may cause higher results. Hematocrits above 60% may cause lower results.
- High concentrations of Uric acid
≥
10 mg/dL, Cholesterol
≥
600 mg/dL, and Ascorbic acid (Vitamin C)
≥
5 mg/dL may interfere with the glucose test causing inaccurate test results.
- Do not perform the blood glucose test at temperatures below 10°C (50°F) or above 40°C (104°F),
nor below 10% or above 90% relative humidity.
- iGlucose Blood Glucose Test Strips are designed for use with capillary whole blood samples. Do not
use serum or plasma samples.
- Not for screening or diagnosis of diabetes mellitus.
