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control solutions

Intended Use

Microdot® Control Solutions are for use only with the microdot® Meter and microdot® Test Strips. They allow you to check that the meter and test strips are working correctly and that you are testing correctly. You should do control solution tests routinely to check that you are getting accurate results.

Summary

Microdot® Control Solutions contain a known amount of glucose. A test with a microdot® Control Solution is like a blood test except that you use a Control Solution instead of blood. The test result using a Control Solution should fall within the range of results printed on your vial of strips.

 

CAUTION: The control solution range printed on the test strip vial is only for control solution. It is not a recommended range for your blood glucose level. This should be discussed with your doctor.

WHEN SHOULD YOU RUN A CONTROL SOLUTION TEST?

  • Before you first use your new microdot® meter, practice with a control. When you can do three tests in a row correctly,
    you will be able to use the meter successfully.

  • When you begin using a new vial of strips.

  • At least once a week.

  • When you think that the meter or strips are not working correctly.

  • When your test results are not consistent with your symptoms, or when you think your results are not accurate.

  • If the meter is dropped.

  • Test result that is within the expected range shows that the meter and strips are working correctly and that you are testing correctly.

Chemistry

Microdot® Control Solutions are blue aqueous solutions containing a range of approximately a 0.04 to 0.3% D-glucose for low, normal and high values.

Precautions & Limitations

Microdot® Control Solutions must only be used outside of the body (in vitro diagnostic use)

  • Microdot® Control Solutions are made only for the microdot® Blood Glucose Monitoring System. Do not use any other brand of control solutions for testing your microdot® system.

  • Check the expiry date on the vials. Do not use after the expiration date.

  • Shake the vials before use. Discard the first drop of microdot® Control Solution, and wipe off the tip to ensure a good sample and an accurate result.

  • Use only for three months after first opening. Record the discard date (date opened plus three months) on the control solution vials.

  • Storage and Handling. Store the control solution at room temperature between 50 and 86°F (10 and 30°C).Do not refrigerate. Do not freeze.Do not use beyond expiration date or beyond 90 days after opening

Test Procedure

To perform a test with microdot® Control Solution, follow the instructions printed in your microdot® User Manual that came with the system. In addition, follow these instructions when you test with Control Solution:

  • Before using control solutions wash your hands thoroughly.

  • The meter, Control Solution, and strips must be at room temperature (66-77°F /20-25°C) before testing. If they have been stored outside room temperature, be sure to give them time to adjust to room temperature before using.

  • Shake the Control Solution well before using.

  • Discard the first drop of Control Solution you squeeze out.

  • Apply the drop of Control Solution to the top edge of the strip. You may also apply a drop to your finger and test as if it were a drop of blood (See test strip instructions.)

Unexpected Results

At room temperature, the Control Solution results should fall within the range printed on the test strip vial label. If test results fall outside the expected range, repeat the test. Results that fall outside the expected range may indicate:

  • An error in your method.

  • Expired or contaminated Control Solution.

  • Damaged or outdated strips.

  • A problem with the meter.

  • Control Solution that is too warm or too cool.

  • Failure to discard the first drop of Control Solution and to wipe the vial tip clean.

  • Failure to shake the Control Solution vial well.

  • Incorrect test strip code number used.

IMPORTANT:

If you continue to get results that fall outside the expected ranges, call Customer Service. DO NOT test your blood until you obtain control results that fall within the expected range.

Availability:

microdot® Control Solutions are available from authorized distributors. See your System User Manual for the details of your customer service.