OneTouch Ultra Plus™ Test Strips:
- In vitro diagnostic. For self-testing.
IMPORTANT:
- Please read this insert and your User Guide or Owner's Booklet before using. The User Guide or Owner's Booklet has full instructions for blood glucose and control solution testing.
- Do Not use new test strips if the vial is open or damaged in any way. This could lead to error messages or inaccurate blood glucose results.
- Contact Customer Care right away if you have questions about your test strips, test results or these instructions.
- Refer to your User Guide or Owner's Booklet for important information about cleaning and disinfecting your meter, lancing device, and caps.
- The meter and lancing device are for single patient use. Do Not share them with anyone including other family members! Do Not use on multiple patients! All parts of the kit are considered infectious or potentially infectious and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.
- WARNING: Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV) or other bloodborne pathogens.
Testing your Blood Glucose:
- Read your system User Guide or Owner's Booklet for instructions on running a blood test and getting a blood sample.
Test Results:
- The OneTouch Ultra Plus Flex™ Meter shows results between 20 and 600 mg/dL.
- Read these cautions when your test results are higher or lower than what you expect.
- CAUTION:
- Low glucose results
- If your blood glucose result is below 70 mg/dL or a low glucose warning is displayed, (meaning the result is less than 20 mg/dL), it may mean hypoglycemia (low blood glucose). You may need to treat low glucose right away. Follow your healthcare professional's advice. The result could be due to a test error, but it is safer to treat first, then test again.
- High glucose results
- If your test result is above 180 mg/dL, it may mean high blood glucose (hyperglycemia). You should think about re-testing. Talk to your healthcare professional if you are concerned about high blood glucose.
- A high glucose warning is shown when your blood glucose level is over 600 mg/dL. You may have very high blood glucose (severe hyperglycemia). Re-test your blood glucose. If the result is a high glucose warning again, this indicates a severe problem with your blood glucose control. Obtain and follow instructions from your healthcare professional right away.
- Repeated unexpected glucose results
- If you get repeated unexpected results:
- Run a control solution test to check your system.
- Make sure you follow all instructions in your User Guide or Owner's Booklet.
- If your symptoms don't match your blood glucose results, call your healthcare professional.
- Never ignore symptoms or make significant changes to your diabetes management program without speaking to your healthcare professional.
Range of Expected Values:
- Blood glucose management requires the help of a healthcare professional. Talk to your healthcare professional about:
- The target blood glucose range that is right for you.
- When to test.
- What your blood glucose results mean.
- Expected blood glucose levels for non-pregnant people without diabetes1:
-
- 1American Diabetes Association, Standards of Medical Care in Diabetes, Diabetes Care Vol. 41, Supplement 1, S1-S2, January 2018.
- Time: Fasting
- Range, mg/dL: Less than 100
- Time: 2 hours after meals
- Range, mg/dL: Less than 140
Limitations of Procedure:
- Use OneTouch Ultra Plus™ Test Strips under the following conditions to ensure accurate results:
- The OneTouch Ultra Plus Flex™ Meter is intended to be used by a single patient and should not be shared.
- The OneTouch Ultra Plus Flex™ Meter is not to be used for the diagnosis of or screening of diabetes or for neonatal use.
- The OneTouch Ultra Plus Flex™ Meter is not for use on critically ill patients, patients in shock, severely dehydrated patients or hyperosmolar patients (with or without ketosis).
- Hematocrit is the percentage of red blood cells in the blood. Extremes in hematocrit may affect test results. Hematocrit levels below 20% may cause false high readings. Hematocrit levels over 60% may cause false low readings. Talk to your healthcare professional if you don't know your hematocrit level.
- Do Not use the OneTouch Ultra Plus Flex™ System for alternate site testing (AST).
- OneTouch Ultra Plus™ Test Strips should not be used at altitudes above 10,000 feet as there may be an adverse effect on test results.
- If you have medical conditions that are associated with high uric acid level or hyperuricemia (e.g. Gout), then please check with your doctor before using the OneTouch Ultra Plus Flex™ Meter. Uric acid at concentrations greater than 8 mg/dL can interfere with glucose measurements.
- If you take drugs containing acetaminophen (e.g. Tylenol etc.) or Dopamine at doses higher than the recommended high therapeutic level, then you may obtain inaccurate readings from the OneTouch Ultra Plus Flex™ Meter. Please check with your doctor if you are unsure.
- The following table provides interfering levels for the OneTouch Ultra Plus Flex™ Meter:
- CAUTION: The OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System should not be used within 24 hours of receiving a D-xylose absorption test as it may cause inaccurately high glucose results with your meter.
- Do Not use the OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System if you are being treated for organophosphate poisoning with Pralidoxime (PAM) as it may cause inaccurate glucose results with your meter.
- Dehydration and low glucose results
- You may get false low glucose results if you are severely dehydrated. If you think this is the case, contact your healthcare professional right away.
