LifeScan has discontinued the manufacturing the OneTouch Ultra and OneTouch UltraSmart Meters, effective December 31, 2012. This action was taken due to a shift in demand from these products to the newer OneTouch Brand Blood Glucose Meters and not the result of any safety issues. The information below is for historical purposes for patients who may still be using the OneTouch Ultra meters.
What is the OneTouch Ultra?
The OneTouch Ultra is a small portable blood glucose monitoring system that can be used by patients suffering from diabetes. It consists of a meter, testing strips, and a control solution.
How does it work?
The OneTouch Ultra measures the glucose content of a blood sample by means of an electrical current produced in the test strip and measured by the meter. Test results are "plasma-calibrated". This makes it easier for patients and caregivers to compare meter results with laboratory tests.
Blood glucose monitoring plays an important role in diabetes control. A long-term study showed that keeping blood glucose levels close to normal can reduce the risk of diabetes complications by up to 60%.
Test results with the OneTouch Ultra Blood Glucose Monitoring System are presented in milligrams/deciliter (mg/dL), ranging from 20 to 600 mg/dL. If the glucose measurement “mg/dL” unit does not appear when results are displayed, or for other questions regarding the OneTouch Ultra Blood Glucose Monitoring System call your healthcare provider or Lifescan Customer Service at 1 800 227-8862.
Review the OneTouch Ultra Blood Glucose Monitoring System Owner’s Manual for all instructions on meter set-up and use, battery information and care. A review of meter display messages, what they mean, and what action you should take is also included in the Owner’s Manual.
Before Using the OneTouch Ultra
If you have been using another type of meter - one that provides whole-blood results - you may notice that your test results with the OneTouch Ultra system are about 12% higher.
Use no other test strips or control solution other than OneTouch Ultra brand with your meter.
The OneTouch Ultra system is intended for use outside the body (in vitro diagnostic use). It should be used only for testing fresh capillary whole blood samples for glucose (sugar). It should not be used for the diagnosis of diabetes or for testing newborns.
Before using any product to test your blood glucose, read all instructions and practice the test. Do all quality control checks as directed and consult with a diabetes healthcare professional. These recommendations apply to all blood glucose monitoring systems and are supported by the American Association of Diabetes Educators, the American Diabetes Association, the U.S. Food and Drug Administration, and the Advanced Medical Technology Association.
Dehydration: Severe dehydration resulting from excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately.
Low glucose results: If your test result is lower than 70 mg/dL or is shown as LO, it may mean hypoglycemia (low blood glucose). This may require immediate treatment according to your healthcare professional's recommendations. Although this result could be due to a test error, it is safer to treat first, and then repeat the test.
High glucose results: If your test result is greater than 180 mg/dL or is shown as HI, it may mean hyperglycemia (high blood glucose). If you do not have symptoms, first repeat the test. Your healthcare professional can work with you to decide what actions, if any, you should take if you continue to get results higher than 180 mg/dL or if you have symptoms.
Repeated unexpected results: If you continue to get unexpected results, check your system with control solution. See Checking the System with Control Solution on pages 1319. If you are experiencing symptoms that are not consistent with your blood glucose results and you have followed all instructions in this booklet, call your healthcare professional. Never ignore symptoms or make significant changes to your diabetes control program without speaking to your healthcare professional.
Hematocrit: A hematocrit (percentage of your blood that is red blood cells) that is either very high (above 55%) or very low (below 30%) can cause false results.
Comparing laboratory and meter results: Both OneTouch Ultra Meter test results and laboratory test results are both expressed in plasma-equivalent units. However, meter results may differ from laboratory results due to normal variation. The OneTouch Ultra Meter glucose value should agree within +/-20 percent under normal conditions, and that variation is considered accurate.
However, results can vary more than +/-20 percent in some situations. Blood glucose levels can change quickly over short periods of time due to meals, exercise, hematocrit levels, dehydration, medications, or stress.
It is best to fast for eight hours before doing comparison tests. Check with your healthcare provider prior to fasting. See the OneTouch Ultra Test Strip Package insert for important information on guidelines for making an accurate comparison between meter and laboratory results.
To make an accurate comparison between meter and laboratory results, follow the guidelines described in the OneTouch Ultra Blood Glucose Monitoring System Owner’s Manual.
WARNING: Keep the meter and testing supplies away from small children. The battery door, test strips, lancets, protective disks, and control solution cap are choking hazards.
Important Test Strip Information
- Store test strip vials in a cool, dry place below 86F (30C). Keep away from direct sunlight and heat. Do Not refrigerate.
- Store test strips in their original vial only. To avoid damage or contamination, Do Not transfer test strips to any other place.
- After removing a test strip from the vial, replace the vial cap immediately and close it tightly.
- Use each test strip immediately after removing it from the vial.
- Do Not use test strips from any vial that is damaged or left open to air.
- Write the discard date (3 months after first opening the vial) on the vial label when you first open it. Discard remaining OneTouch Ultra Test Strips after the discard date. Do Not use test strips beyond the expiration (printed on package) or discard date, whichever comes first, because they may cause inaccurate results.
- Avoid getting dirt, food or liquids on the test strip. With clean, dry hands, you may touch the test strip anywhere on its surface.
- Do Not bend, cut, or alter a OneTouch Ultra Test Strip in any way.
- OneTouch Ultra Test Strips are for single use only. Never reuse a test strip that has had either blood or control solution applied to it.
- Apply only OneTouch Ultra Control Solution or a blood sample to the test strip.
- Refer to additional information in the OneTouch Ultra Test Strip package.
WARNING: Do Not swallow test strips. The test strip vial may contain drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation.
CONTACT INFORMATION: For additional information, call your healthcare provider or Lifescan Customer Service at 1 800 227-8862.