A01.

Cause:

1. Humidity or heat may cause damage to the test strips.
2. Expired or defective test strips.
3. Insufficient amount and improper placement of blood on the test strips.
4. The code number displayed on the meter does not match the code number printed on the test strip vial label.
5. The meters may have been dropped or its electrical components may have worn out.
6. Meters and laboratory equipment may be calibrated or set to measure blood glucose in different ways and will give different results.
7. User exposed test strips to air more than a few minutes.

Perform:

1. You should perform quality control testing to make sure that your glucose testing is accurate and reliable.
2. Follow the instructional setup by your healthcare professional; obtain professional training and guidance for the use of your particular meter.
3. You can test your glucose level while your healthcare provider watches your technique to make sure you are using the meter correctly.
4. Use within 90 days of first opening your test strip vial or 18 months from production date.
5. Storage condition for test strips: 10℃ ~40℃, < 85% RH.
6. Make sure the blood sample used for testing is capillary whole blood.
7. Make sure the code number displayed on the meter matches the test strips' vial label.
8. Make sure you are using new strips and supplies.
9. Check your testing technique routinely with your healthcare professional.
10. Follow the manufacturer’s owner’s manual　carefully.
11. Don’t expose the test strips to air for more than a few minutes..

A02.

Test the accuracy by calibrating with the manufacturer's control solution. Follow the instruction in the owner's manual. If your result differs from the range printed on the control solution label by 20% or more, it could be a defective meter, strip, or control solution.

Factors that affect glucose meter performance.

The accuracy of your test results depends partly on the quality of your meter and test strips and your training. Other factors can also make a difference in the accuracy of your results.

Hematocrit, is the amount of red blood cells in the blood. Patients with higher hematocrit values will usually test lower for their blood glucose level. If you have abnormal hematocrit value you should discuss its possible effect on your glucose testing (and HbA1C testing) with your health care provider. Anemia and sickle cell anemia are two conditions that affect hematocrit values.

Other substances, many other substances may interfear with your testing process. These include uric acid (a natural substance in the body that can be more concentrated in some people with diabetes), glutathione (an “anti-oxidant” also called “GSH), and ascorbic acid (vitamin C). You should check the package insert for each meter to find what substances might affect its testing accuracy, and discuss your concerns with your health care provider.

Altitude, temperature and humidity, altitude, room temperature, and humidity can cause unpredictable effects on glucose results. Check the meter and test strips according to the instructions.

In the world of blood glucose monitoring, there are two methods to measure blood glucose value - whole blood and plasma. All blood glucose meters measure the glucose levels in whole red blood. Laboratory equipment measure glucose levels in plasma, the watery substance in your blood.

Whole blood test results are about 10%~15% lower than plasma test results. Blood glucose meters are considered clinically accurate if it falls within +/- 20% of an accepted reference result. E.g. 200 mg/dL plasma/1.12 = 178.6 mg/dL whole blood. Plasma calibrated meter would be accurate if it gave you a result anywhere between 142.9 and 214.32.

The control solution is used to check that the meter and the test strips are working together as a system, and that you are doing the test correctly. When testing with the control solution, the result should fall within the range printed on the strip vial.

This is an important step -- Press the “M” button to enter the control solution mode. The word “CTL” appears on LCD.

Perform:

1. Use FORA control solution only.
2. Don’t use it expired. Discard 90 days after opening.
3. This control solution should be at room temperature (20 ~25℃ / 68~77℉)。
4. You should follow step 2  in the owner’s manual to perform the control solution test.
5. Shake the control solution gently and discard the first drop, then repeat the test again.
6. This test strip maybe contaminated; you have to repeat the test with a new test strip.
7. When you perform the control solution testing, you must squeeze the vial to get a hanging drop and place the drop on your fingertip.
8. How to perform controlled solution testing? This is an important step -- Press the "M" button to enter the control solution mode. The word "CTL" appears on LCD.

Lancing devices (lancets) are fine, sharp-pointed blades or needles used to pierce the skin to draw a sample of blood for glucose testing. There are many types of lancets and some have protective caps.
The systems are designed for individual homecare use (e.g. diabetic self-monitoring), and alternative site puncture.

Most automatic lancing devices consist of a hand-held tube with a spring-loaded lancet. To obtain a blood sample, hold the device against your skin, press a button to release the lancet. Before the next use, you must clean your lancing device.

Prevention of re-use: residual blood on the lancet can result in cross-contamination. If you reuse a lancet you are at risk of infections.

Code numbers are used to calibrate the meters with the test strips for accurate results. The meter must be coded in its first use, when changing the strip vial.

One Code: You don't have to change the code if it's only one code. Simply insert your strip into the meter and the code will automatically be recognized.

Step 1: Match the model of the meter and the vial of test strips.

Step 2: Insert the test strips into the meter and turn the meter on.

Step 3:Match the code numbers on the meter with the test strips' vial.

•  Keep your meter clean.
•  Test your meter regularly with control solution.
•  Store your meter and supplies properly, heat and humidity can damage test strips.
•  Replace the bottle cap promptly after removing the test strip.

Use FORA control solution to perform tests during the following situations:

•  Every time you purchase a new box of FORA test strips.
•  Radom sampling of test strips.
•  Whenever you get unusual results.

Some FORA blood glucose monitoring systems allow you to obtain the blood sample from an alternative site, such as your forearm, upper arm…etc.

Notices: Alternative Site Testing is not for everyone. Limitations are as follows:

• You think your blood glucose levels are low
• You have just taken insulin.
• If you question your test results.
• If you feel ill.
• When you are hypoglycemic.
• When your blood glucose levels rapidly change, for example after a meal or exercise.

Sample size can affect the result. Always follow the instructions in the Owner's Manual for applying blood to the test strip and make sure that the blood sample has completely filled the confirmation window of the test strip.

Can the hematocrit levels affect results?

Hematocrit levels can affect results whether the sample is obtained from forearm or from fingertips. Hematocrit levels less than 30% may cause false high readings and hematocrit levels greater than 55% may cause false low readings. If you don't know your hematocrit level, consult with your health care professional. Hematocrit levels may be affected by too much squeezing during site preparation.