According to the Office of Invitro Diagnostic Devise Evaluation and Safety. (OIVD)
“The US Food and Drug Administration (FDA), Abbott Diabetes Care and LifeScan are aware of instances where incorrect results were obtained using LifeScan One Touch Ultra test strips with Abbott Precision Xtra meters. One Touch Ultra test strips are not intended for use with Precision Xtra meters, and doing so may lead to lower than expected blood glucose results. Similar problems can occur if other brands and models of meters and strips are not used in proper combination.”
OVID further states that, “it is important for users to understand that if they use a test strip that is not recommended for their meter, the device may fail to give results or may generate inaccurate results.” OIVD recommendations are as follows:
“Users of blood glucose meters should carefully read the Owner’s Manual and only use the test strips that are specified for that meter.
As an additional check, the test strip inserts identify the blood glucose meters with which they should be used.
Healthcare providers and pharmacists should advice their patients to use only test strips that are compatible with their meter.”
A report from the American Diabetes Association states that, “there are 23.6 million people in the United States or 8% of the population who have diabetes.”
This is a large population of people who the preceding critical and valuable information could affect if they are not aware of the dangers of using test strips that are not compatible with their meters.
The FDA has the responsibility for regulating glucose meters and strips.
The FDA is responsible to review all glucose meters and strips before they are released for marketing to the public.
What does the FDA look for in their review?
The manufacturer must demonstrate the acceptable accuracy of consistency of glucose measurement at: high, medium and low levels of glucose compared to glucose meters already on the market.
The manufacturer must also make sure the that the test strips and the meter are compatible.
The software of the glucose meter is an important feature. The software controls the testing data storage and the display of the readings or test results.
With all the regulations of the FDA regarding glucose meters and test strips it would all be futile if the end user or consumer did not follow the manufacture’s instructions.
The following information regarding glucose meters and test strips should be helpful.
Tips Regarding Glucose Monitors and Test Strips.
A glucose meter is a portable medical devise for people with diabetes to check the approximate amount of glucose in a drop of blood.
A test strip is a plastic strip designed to be fed into the meter to accept the drop of blood to be measured and the result is displayed on the meter.
There are 25 different glucose meters available on the market and they all use different test strips.
Test strips are for one time use only.
Test strips are only good for 90 days after a new vial is opened.
Check the expiration date of the strips and do not use them after that date to avoid getting inaccurate test results.
Follow the manufacture’s instruction about how to store and handle the meter and the test strips.
With advanced technology monitoring your blood sugar is getting easier and easier.
There are many new features in the newer meters. For example:
Smaller drop of blood is needed for the testing.
Some meters need no coding when you change to a new bottle of strips.
There is the option with some meters to use other parts of your body to obtain the drop of blood rather than from your finger.
Use these new features to your advantage by following the manufacturer’s instructions.
For diabetics meters and test strips are life lines but they must be used correctly.