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 Service right away if
you have questions about your test strips, test results or these instructions. As your partner in
diabetes care, we welcome you to contact us (7 days a week, 8:00 AM - 8:00 PM Eastern Time) at
1 888 567-3003 (English), 1 888 567-3010 (Español), or www.OneTouch.com.
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
biohazardous and can potentially transmit infectious diseases, even after you have performed
cleaning and disinfection.
Intended Use
The OneTouch Verio
®
Test Strips are used with the OneTouch Verio
®
Family of Blood Glucose
Monitoring Systems (OneTouch Verio
®
, OneTouch Verio IQ
®
, OneTouch Verio Sync
®
, OneTouch Verio
Flex
®
, OneTouch Verio Reflect
™
) for the quantitative measurement of glucose (sugar) in fresh capillary
whole blood samples drawn from the fingertips. The OneTouch Verio
®
Family of Blood Glucose
Monitoring Systems is intended to be used by a single person and should not be shared.
The OneTouch Verio
®
Family of Blood Glucose Monitoring Systems is not to be used for the diagnosis
of or screening of diabetes or for neonatal use.
Refer to the User Guide or Owner's Booklet that came with your meter for the full system intended use.
Storage and Handling
• The expiration date is printed on the vial.
• The discard date is 6 months after you first open a test strip vial. When you open a new vial, write
the discard date on the label.
•
Do Not
use after the expiration or discard date, whichever comes first.
• Store the test strip vial in a cool dry place between 41°F and 86°F and below 65% relative humidity.
Keep away from direct sunlight and heat.
Do Not store the test strip vial in rooms where the air
is humid such as the kitchen, laundry room or bathroom.
Exposure to temperatures outside the
storage limits, as well as moisture and humidity, may cause inaccurate readings.
• Store your test strips in the
vial only
. To avoid damage or contamination,
Do Not
put test strips in
any other container.
• Open the vial
only
when taking out a test strip for use.
• Close the vial lid tightly right away after removing a test strip. Use each test strip
as soon as you
take it out
of the vial.
•
Do Not
use test strips from a vial that is damaged or left open to air.
•
Do Not
get dirt, food or liquids on the test strip. You may touch the test strip anywhere on its
surface with clean, dry hands.
•
Do Not
bend, cut or alter test strips in any way.
• Test strips are for single use only.
•
Never reuse a test strip that already has blood or control solution on it.
• Make sure your meter and test strips are about the same temperature before you test.
• Apply only OneTouch Verio
®
Control Solution or a blood sample to the test strip.
•
Do Not
put the used test strip back in the vial after taking a test.
• Used test strips may be considered biohazardous waste in your area. Be sure to follow your
healthcare professional’s advice or local laws when throwing them away.
WARNING: Keep the test strip vial away from children. Test strips are a choking hazard.
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. Do Not ingest or swallow any
items.
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 Verio
®
Family of Meters 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 diabetes
1
:
Time
Range, mg/dL
Fasting
Less than 100
2 hours after meals
Less than 140
1
American Diabetes Association, Standards of Medical Care in Diabetes, Diabetes Care Vol. 38,
Supplement 1, S1-S94, January 2015.
Checking the System
Use only OneTouch Verio
®
Control Solution
A control solution test is used to check that:
• The meter and test strips are working together properly.
• You are doing the test correctly.
Do a control solution test
• When you open a new vial of test strips.
• If you think the meter or test strips are not working properly.
• If you get repeated unexpected blood glucose results.
• If you drop or damage the meter.
Read your system User Guide or Owner's Booklet for instructions on how to run a control solution
test.
Limitations of Procedure
OneTouch Verio
®
Test Strips give accurate results under the following conditions:
• Use only fresh capillary whole blood.
Do Not
use serum or plasma.
• 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.
• OneTouch Verio
®
Test Strips may be used at altitudes up to 10,000 feet with no effect on test
results.
• Test results may be falsely low if the patient is severely dehydrated, in shock or in a hyperosmolar
state (with or without ketosis).
• Critically ill patients should not be tested with the OneTouch Verio
®
Family of Meters.
The following table provides interfering levels for the OneTouch Verio
®
Family of Meters
Interfering Substance
OneTouch Verio
®
Family of Meters
Tolazamide
Concentrations greater than 10.8 mg/dL may
cause falsely low results
Uric Acid
Concentrations greater than 8 mg/dL may cause
falsely low results
CAUTION:
• The OneTouch Verio
®
Family of Blood Glucose Monitoring Systems should not be used for
patients within 24 hours of receiving a D-xylose absorption test as it may cause inaccurately
high results.
•
Do Not
use the OneTouch Verio
®
Family of Blood Glucose Monitoring Systems when PAM
(Pralidoxime) is known or suspected to be in the patient's whole blood sample.
•
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.
Alternate Site Limitations
OneTouch Verio
®
Family of Meters are not indicated for Alternate site testing (AST).
Refer to the User Guide or Owner's Booklet that came with your meter for the full system intended use.
Test Principle
The OneTouch Verio
®
Family of Meters is plasma-calibrated for easy comparison of results with lab
methods. Glucose in the blood sample mixes with special chemicals on the test strip to produce
an electrical current. The strength of the current changes with the amount of glucose in the blood
sample. The OneTouch Verio
®
Family of Meters measures the current, calculates your blood glucose
level and shows your result.
Reagent Composition
Each test strip contains: flavin adenine dinucleotide dependent glucose dehydrogenase or FAD-GDH
(from Aspergillus sp.) - 2 U; potassium ferricyanide 41 µg; and other ingredients (buffer, etc.). The vial
contains a drying agent.
Performance Characteristics
The performance of the OneTouch Verio
®
Test Strip has been evaluated both in laboratory and in
clinical tests.
Measurement Range: The measurement range of the OneTouch Verio
®
Family of Meters is 20 to
600 mg/dL.
The following data is representative of the OneTouch Verio
®
Family of Meters. Refer to your system
Owner’s Booklet for performance data specific to your system.
System Accuracy
Samples from 100 patients were tested using both the OneTouch Verio
®
System and the YSI 2300
Glucose Analyzer laboratory instrument.
System Accuracy Results for Glucose Concentrations <75 mg/dL
Percent (and number) of meter results that match the laboratory test
Within ±5 mg/dL
Within ±10 mg/dL
Within ±15 mg/dL
50.7% (35/69)
89.9% (62/69)
100.0% (69/69)
System Accuracy Results for Glucose Concentrations ≥75 mg/dL
Percent (and number) of meter results that match the laboratory test
Within ±5%
Within ±10%
Within ±15%
Within ±20%
62.3% (144/231)
89.2% (206/231)
97.8% (226/231)
100% (231/231)
System Accuracy Results across the entire Glucose Range
Percent (and number) of meter results that match the laboratory test
Within ±15 mg/dL or ±20%
100% (300/300)
Regression Statistics
Samples were tested on each of three test strip lots. Results indicate that the OneTouch Verio
®
System
compares well with a laboratory method.
# of Subjects
# of Tests
Slope
Intercept (mg/dL)
100
300
0.99
5.14
95% CI Slope
95% CI Intercept
(mg/dL)
Std. Error (Sy.x)
(mg/dL)
R
2
0.98 to 1.00
3.06 to 7.23
9.72
0.99
Precision
Within Run Precision (300 Venous Blood Tests per glucose level)
Data generated using the OmniPod
®
Insulin Management System.
Target Glucose
(mg/dL)
Mean Glucose
(mg/dL)
Standard Deviation
(mg/dL)
Coefficient of
Variation (%)
40
47.0
1.37
2.92
100
105.8
2.62
2.47
130
136.4
3.62
2.65
200
212.6
5.21
2.45
350
366.8
9.16
2.50
Results show that the greatest variability observed between test strips when tested with blood is 2.65%
or less.
Total Precision (200 Control Solution Tests per glucose level)
Data generated using the OneTouch Verio IQ
®
Meter.
Glucose Level Ranges
(mg/dL)
Mean Glucose
(mg/dL)
Standard Deviation
(mg/dL)
Coefficient of
Variation (%)
Level 2 (38-62)
50.31
1.77
3.52
Level 3 (102-138)
117.14
2.70
2.31
Level 4 (298-403)
342.34
8.68
2.53
IMPORTANT:
For instructions, technical data and a list of symbols used, read your system User
Guide or Owner's Booklet.
OUR COMMITMENT TO YOU
Our goal is to provide you with quality healthcare products and dedicated customer service. If you are
not fully satisfied with this product, or if you have questions about the use of any LifeScan product,
contact Customer Service. As your partner in diabetes care, we welcome you to contact us (7 days
a week, 8:00 AM - 8:00 PM Eastern Time) at 1 888 567-3003 (English), 1 888 567-3010 (Español), or
www.OneTouch.com. If you cannot reach Customer Service, contact your healthcare professional
for advice.
For a complete list of all symbols used, refer to the User Guide or Owner's Booklet that came with
your system.
Test S
trips
Tiras r
eactivas
AW 06703909
A
