Compound Limitation
Additional Limitations
Test Strips and 1 Code Key
PROFESSIONAL USE
What Do the Test Strips Do?
The test strips are to be used with the
ACCU-CHEK Advantage and ACCU-CHEK Complete
meters, and with the AccuData GTS Plus/GTS,
ACCU-CHEK HQ, and ACCU-CHEK Inform systems.
These systems are designed to quantitatively
measure the concentration of glucose in whole
blood. The device is indicated for professional use
and over-the-counter sale. Professionals may use
the test strips to test capillary, venous, arterial, and
neonate (including cord) whole blood samples; lay
use is limited to capillary whole blood testing.
Precision: Within-run precision using control
Bilirubin (unconjugated) > 20 mg/dL
Warning: If you are currently using drug
therapies that contain or break down into
maltose or galactose, do NOT use the
ACCU-CHEK Comfort Curve test strip. Certain
therapies can elevate the levels of maltose or
galactose in your blood, leading to falsely elevated
blood sugar test results.
For example:
• Peritoneal dialysis solutions containing
icodextrin (e.g., Extraneal)
• Certain types of intravenous immunoglobulin
therapies (e.g., Octagam 5%)
• Intravenous solutions containing maltose as a
means for patient hydration
Note: the list of drugs mentioned above is not
intended to be all inclusive and may not include
recently introduced, new drugs. Therefore, always
consult the drug package insert to determine
whether it contains or breaks down into maltose
or galactose.
1. These test strips are for testing capillary,
venous, neonatal, cord blood, and arterial blood.
2. Do not use during xylose absorption testing.
3. Hematocrit range is 20-65% for glucose
measurements less than 200 mg/dL and
20-55% for glucose measurements greater than
200 mg/dL.
4. System measurement range is 10-600 mg/dL.
5. This system has been tested at altitudes
ranging from sea level to 10,150 feet.
6. In situations of decreased peripheral blood
flow, fingerstick blood testing may not be
appropriate, as it may not reflect the true
physiological state. Examples would include, but
are not limited to: severe dehydration caused
by diabetic ketoacidosis or the hyperglycemic
hyperosmolar nonketotic state, hypotension,
shock, decompensated heart failure NYHA Class
IV, or peripheral arterial occusive disease.3,4,5
7. The system has been tested with neonatal
blood (capillary, cord blood). As a matter of
good clinical practice, caution is advised in the
interpretation of neonate glucose values below
50 mg/dL. Please follow the recommendations
for follow-up care that have been set by
your institution for critical glucose values in
neonates.
8. The following compounds, when determined to
be in excess of their limitation, may produce
elevated glucose results:
• Galactose >10 mg/dL can give falsely
elevated test results. Glucose values in
neonates demonstrating symptoms of
galactosemia should be confirmed with a
laboratory reference.
• Maltose >16 mg/dL delivered intravenously,
can give falsely elevated test results.
Performance Characteristics solutions and blood was excellent at all levels
Lipemic Samples > 5000 mg/dL
Acetaminophen > 8 mg/dL
Uric acid:
Hypoglycemic range > 10 mg/dL
Euglycemic range > 12 mg/dL
Hyperglycemic range > 16 mg/dL
Specimen Collection
and Preparation
by Healthcare Professionals
A drop of fresh, whole blood is required to perform
a blood glucose test. Capillary blood from a
fingerstick can be used. Venous, neonatal, or
arterial blood may also be used only if drawn by
healthcare professionals. When collecting any type
of sample, professionals need to follow universal
blood collection precautions and guidelines.
Fingerstick Samples
To take a fingerstick blood sample, first wash the
patient’s hands in warm, soapy water. Rinse and
dry completely. If you use alcohol swabs, wipe the
finger tip completely. In either case, rub (“milk”)
the finger to increase blood flow. Prepare the lancet
device according to the manufacturer’s instructions.
Venous or Arterial Samples
When you perform a glucose test in a clinical
setting using venous or arterial blood samples, the
following criteria need to be met.
• To minimize the effect of glycolysis, venous or
arterial blood glucose tests need to be performed
within 30 minutes of drawing the sample. When
filling plastic pipettes, avoid air bubbles which
could give falsely low test results.
• For best results with venous and arterial blood,
the following anticoagulants/preservatives are
recommended: heparin and EDTA. Serum
separator tubes are acceptable if whole blood
is used immediately. Iodoacetate or fluoride-
containing anticoagulants are not recommended.
• Take caution to clear arterial lines before the
blood sample is drawn and applied to the
test strips.
What Happens if I Have Problems or Questions?
Call the ACCU-CHEK Customer Care Service Center 24 hours a day, 365 days a year.
Healthcare Professionals: 1-800-440-3638.
MERCHANTABILITY OR FITNESS FOR A PARTICULAR
References PURPOSE, IF ANY IS IMPLIED FOR THE SALE OF
The ACCU-CHEK Comfort Curve test strips are tested: 1. Stedman, TL, Stedman’s Medical Dictionary, THE TEST STRIPS, SHALL EXTEND FOR A LONGER
whole blood referenced and have been calibrated to Control Low Mid High 27th Edition, p. 2082, 1999. DURATION THAN THE EXPIRATION DATE OF THE
deliver plasma-like values for easier comparison to Solutions (mg/dL) (mg/dL) (mg/dL) TEST STRIPS.
2. American Diabetes Association, Clinical Practice
lab results. N 20 20 20 Recommendations 2003, Diabetes Care, Vol. 26. Some states do not allow limitations on how long
mean 57 128 328 Supplement 1, p. S21-S24, 2003. an implied warranty will last or the exclusion of
Accuracy: Studies were conducted by trained incidental or consequential damages, so the above
3. Atkin, S.H.: Dasmahapatra A.; Jaker, M.A.;
technicians at two physician’s offices with capillary SD 2.8 3.9 9.3 limitation and exclusion may not apply to you. This
Chorost, M.I.; Reddy, S., Fingerstick Glucose
and venous blood samples with the following CV – 3.1 2.8 warranty gives you specific legal rights, which vary
Determination in Shock. Annals of Internal
results: from state to state.
Blood Medicine, 114:1020-1024 (1991).
Capillary Blood Venous Blood
N = 187 N = 218 N 20 20 20 4. Sander, M.; Low-Beer, T., Misleading Capillary
y = 0.991x + 8.4 y = 0.975x + 3.0 mean 30 143 487 Glucose Measurements. Practical Diabetes,
r = 0.980 r = 0.987 7:210 (1990).
SD 1.5 4.6 15.5
range = 41 - 503 mg/dL range = 41 - 503 mg/dL 5. Wickham, N.W.R.; Achar, K.N.; Cove, D.H.,
CV – 3.2 3.2
Unreliability of Capillary Blood Glucose in
Consumer Blood Study Peripheral Vascular Disease. Practical Diabetes,
This study shows a variation from strip to strip
Studies were conducted where capillary blood 3:100 (1986).
of 3.2%.
sample results obtained by untrained patients from
6. D’Costa, E.J.; Higgins, I.I., et al., Quinoprotein
two physician’s offices gave the following results:
Glucose Dehydrogenase and its Application in
N = 187
an Amperometric Glucose Sensor, Biosensors,
y = 0.985x + 7.5 2:71-87 (1986).
r = 0.977 Reagent Composition
7. Mor, JR and Guamaccia, R.: Assay of Glucose
range = 41 - 503 mg/dL Potassium ferricyanide 43.7% Using an Electrochemical Enzymatic Sensor,
Glucose dehydrogenase** 1.2% Analytical Biochemistry. 79:319-328 (1977).
Arterial Blood Study
Buffer 24.7%
A study was conducted at two hospitals with the 8. Hauge, J.G. Glucose Dehydrogenase of
following results: Stabilizer 19.4% Bacterium Anitratum: an Enzyme with a
N = 143 Nonreactive ingredients 11.0% Novel Prosthetic Group, Journal of Biological
y = 1.045x - 1.3 **(from A. calcoaceticus, recombinant from E. coli) Chemistry, 239:3630-3639 (1964).
r = 0.984 Minimum at time of manufacture.
range = 75 - 388 mg/dL Electrodes contain Palladium.
Neonatal Blood Study
A study was conducted at a hospital with the ACCU-CHEK Comfort Curve
following results: Test Strip LIMITED WARRANTY
N = 105 Test Principle
Roche Diagnostics warrants that your ACCU-CHEK
y = 0.999x - 4.4 Amperometry: Glucose dehydrogenase in the
Comfort Curve test strips will be free from defects
r = 0.981 strip converts the glucose in the blood sample
in materials and workmanship until the product
range = 33 - 153 mg/dL to gluconolactone. This reaction liberates two expiration date printed on the label if the test strips
mean = 87 mg/dL electrons that react with a coenzyme (PQQ) electron are used and stored in the manner described in
HCT range = 30% - 64% acceptor. The complete reaction creates a harmless this package insert and in your ACCU-CHEK blood
HCT mean = 51% electrical current that your meter interprets for your glucose meter Owner’s Booklet. If, prior to the
These studies show that the ACCU-CHEK blood sugar.6,7,8 expiration date of the test strips, there is a defect
Advantage, ACCU-CHEK Complete, AccuData GTS in materials or workmanship, Roche Diagnostics
Plus/GTS, ACCU-CHEK HQ, and ACCU-CHEK Inform will replace the test strips free of charge. Your sole
systems compare well with a plasma lab method. and exclusive remedy with respect to the test strips
shall be replacement. Any warranty claim should be
directed to the ACCU-CHEK Customer Care Service
Center 1-800-858-8072.
THE ABOVE WARRANTY IS EXCLUSIVE OF ALL Visit our website at www.accu-chek.com
OTHER WARRANTIES, AND ROCHE DIAGNOSTICS This product is covered by U.S. Patent Nos. 5,997,817; Re. 36,268; 5,627,075;
MAKES NO OTHER WARRANTIES, EXPRESS OR 5,508,171; 5,053,199; 5,366,609; 5,288,636; and 4,891,319. U.S. Patent
4,891,319 is licensed from Quadrant Holdings Cambridge Limited.
IMPLIED, INCLUDING WITHOUT LIMITATION THE
The Code Key is protected by U.S. Patent Nos. 5,053,199; and 5,366,609.
IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE. IN NO ACCU-CHEK, ACCU-CHEK INFORM, ADVANTAGE, COMFORT CURVE,
VOICEMATE, COMPLETE, and ACCUDATA are trademarks of Roche.
EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE
All other product names and trademarks are the property of their respective
TO THE PURCHASER OR ANY OTHER PERSON owners.
FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRET, Roche Diagnostics
SPECIAL OR PUNITIVE DAMAGES ARISING FROM 9115 Hague Road, Indianapolis, IN 46256
OR IN ANY WAY CONNECTED WITH THE PURCHASE ©2007 Roche Diagnostics. All rights reserved.
OR USE OF THE TEST STRIPS. NO WARRANTY OF
03517462005-0907

Test Strips and 1 Code Key PERSONAL USE
Purpose
You can use these test strips with either the ACCU-CHEK Advantage,
ACCU-CHEK Voicemate or the ACCU-CHEK Complete meters. The test strips,
when used with these meters, tell you how much blood sugar (glucose) is in
your blood with a fingerstick.
Introduction
Testing your blood sugar regularly helps you better manage your diabetes
which can prevent or delay further health problems. Your doctor can tell you
what your healthy blood sugar range is. It is very important to stay in your
healthy range. If your blood sugar is too low, you may experience sweating,
blurred vision, rapid heartbeat, or numbness/tingling of your fingertips or
mouth. If your blood sugar is too high, you may be thirsty, have belly pain,
vomit, have trouble breathing or a headache.
Caution: These test strips are for use outside the body only. Do not eat
these test strips. The cap contains beads to keep the test strips dry.
Do not eat the beads.
Before you start testing
• Carefully read and follow all instructions in the package insert when
testing your blood sugar.
• Your hematocrit (blood count) should be between 20% and 55%. Ask
your doctor if you do not know your hematocrit.
• If you have poor circulation, testing your own blood sugar may not be
right for you. Ask your doctor.
• If you are undergoing peritoneal dialysis with fluids that contain
icodextrin, an active ingredient that breaks down to maltose in the
bloodstream, or are receiving treatment with drugs that contain or
break down into maltose, you should not use the ACCU-CHEK Comfort
Curve test strip. It will cause inaccurate results. Ask your doctor about
alternative testing methods. See the Limitations section.
• Inspect the container of test strips before using them for the first time.
If you see any damage to the container cap, if anything prevents the
cap from closing properly, or if any of the beads have dropped into the
vial, do not use the test strips. Contact the ACCU-CHEK Customer Care
Service Center. Damaged test strips can cause inaccurate results, which
could lead to improper treatment.
• You can use the meter at altitudes from sea level up to 10,150 feet.
Storing the test strips
• Store the test strips in the original container with the cap on. When you
take a test strip out of the container, put the cap back on tightly right
away or the test strips may get damp, which can ruin the test strips,
and lead to a wrong result.
• The temperature symbol means to keep 90°F (32°C)
the container of strips at room temperature
36°F (2°C)
(under 90 °F or 32 °C). Do not freeze the
container of test strips.
• Throw the test strips away if they are past the “Use by” date on the test
strip container. If the “use by” date is missing or cannot be read, do not
use the test strips.
• Use the test strips between 57 °F to 104 °F and less than 85%
humidity. Humidity is the amount of water in the air. Do not keep the
container in rooms where the air is humid such as a kitchen, laundry
room or bathroom.
Handling the test strips
You must use the test strip within three minutes after you take it out of the
container or your result may be wrong, and you will have to repeat your test.
STEP 1 Getting ready to test
1. Get your supplies together. You need the meter, the test strip, the code
key, a lancet device and lancet.
2. When you turn on the meter, check the code number by comparing
the code in the display with the code number on the outside of the
strip container. These numbers must match. If they don’t, refer to your
Owner’s Booklet to get directions on how to change the code key.
3. Get the lancet device ready to use if you are doing a fingerstick. See the
Owner’s Booklet for directions.
STEP 2 Running a control test
(Skip to Step 3 if you have already done this for your container of test strips)
What control solution to use
Use the ACCU-CHEK Comfort Curve control solutions (Cat. No. 2030390,
2030411).
How the control solution works
The control solution contains a known amount of sugar and acts like blood
when you apply it to the test strip.
When you run a control test, you are checking to see if
• You are doing the test right.
• The meter and test strips are working together properly.
When to run a control test
• Each time you open a new container of test strips
• You left the test strip container open or you think the test strips have
been damaged
• The test strips were stored in extreme temperatures or humidity
• You want to check the meter and test strips
• You dropped the meter
• Your blood sugar result does not match the way you feel.
• You want to check if you are testing correctly
How to run a control test
Follow the directions found in the control solution box or the meter Owner’s
Booklet.
What the results mean
Compare the result you get to the range for that level on the test strip
container.
• If your result is inside the range, you know the meter and strips are
working properly. You can now test your blood.
• If your result is outside the range, check the control solution package
insert or your meter Owner’s Booklet.
• If you are still having problems, call the ACCU-CHEK Customer Care
Service Center at 1-800-858-8072. Help is available 24 hours a day,
7 days a week.
STEP 3 Testing your blood
You are now ready to test your blood. Wash and dry your hands.
Read the “Getting a good drop of blood” section of this insert if you have
problems or are new to testing.
Procedure
1. Insert the test strip as far as you can. The meter turns on.
2. When you see the flashing blood drop on the display, do your
fingerstick. You must wait for the flashing blood drop!!
YES NO
3. Touch and hold the drop of blood to the edge of the Comfort Curve. If
you see any yellow in the test strip window after you put the blood drop
on, you can apply a second drop of blood. You must do this within
15 seconds of putting the first drop on the edge of the Comfort Curve.
4. Your blood sugar result appears on the display in 26 seconds.
5. Take the test strip out of the meter. Put the lancet and test strip in a
puncture-proof container (like a coffee can).
STEP 4 Your results
What’s a normal blood sugar result?
The normal fasting blood glucose range for an adult without diabetes is
74-106 mg/dL.1 Two hours after meals, the blood glucose range for an
adult without diabetes is less than 140 mg/dL.2 For people with diabetes:
please consult your doctor for the blood glucose range appropriate for you.
Symptoms of high or low blood sugar
Being aware of the symptoms of high or low blood sugar can help you
understand your test results and decide what to do if they seem unusual.
High blood sugar (hyperglycemia) symptoms: fatigue, increased appetite or
thirst, frequent urination, blurred vision, headache, or general aching.
Low blood sugar (hypoglycemia) symptoms: sweating, trembling, blurred
vision, rapid heartbeat, tingling, or numbness around your mouth or
fingertips.
If you are having any of these symptoms, test your blood sugar. If your
blood sugar result is displayed as HI or LO, and you have symptoms of high
or low blood sugar, follow your doctor’s instructions or contact your doctor.
For example, if your doctor has advised you to immediately treat a low
blood sugar result (such as by eating something), then do so. The meter
reads blood sugar results between 10 and 600 mg/dL. If you get a “HI” or
“Err mg/dL” on the meter, your blood sugar may be over 600 mg/dL.
Unusual Test Results
If your blood sugar result doesn’t reflect how you feel, run a control test.
IF the control test is OK…
Review the test procedure and test yourself again with a new test strip.
If you have done everything correctly and your blood sugar doesn’t
match the way you feel, follow your doctor’s instructions, or contact
your doctor.
Follow the advice of your doctor before you change your
therapy.
IF the control test is NOT OK…
Check this list to see what may be causing the problem:
• Check the expiration date of the test strips and control solutions.
• Does the code number on the test strip container match the code
number in the meter?
• Was the test strip out of the container more than three minutes
before you applied the sample?
• Was the cap kept firmly on the container at all times except when
you got a test strip out?
• Was the test strip container in a very hot or very cold area, or in
humidity?
If none of these apply, call the ACCU-CHEK Customer Care Service
Center at 1-800-858-8072.
Getting a good drop of blood
If you have trouble getting a good drop of blood, here are some tips:
• Wash your hands in warm, soapy water, then rinse and dry thoroughly.
(Warming your fingers can increase blood flow.)
• If you use an alcohol wipe, be sure your fingertip is dry before doing a
fingerstick.
• Let your hand hang by your side. (This increases blood flow.)
• Squeeze your finger at the knuckle for three seconds, then let go.
Repeat.
• Prick your finger, then squeeze at the knuckle to form a drop of blood.
Don’t squeeze too hard.
URGENT! Important Information Please Read
ACCU-CHEK Advantage System
What you need to know
Roche Diagnostics has identified a situation that can occur no more than
once every seven days, during a ten-minute time period, which can cause
an individual result to be incorrectly recorded to your ACCU-CHEK
Advantage memory.
This situation does not affect the result on the display at the time of testing.
This means that you will still receive an accurate reading of your blood
glucose when you view your result on the display immediately after testing.
If you later call up your meter memory, that individual stored result could be
incorrect – meaning low or high or potentially outside the 10-600 mg/dL
reading range.
When could this situation occur?
If the time and date is set in your meter and you perform a test from
12:00 (midnight) to 12:10 a.m., then that result could potentially be
changed when it is stored to the memory of the meter. OR
If the time and date is not set in your meter, one blood glucose test result
every seven days could be incorrectly stored in your meter memory.
What should you do?
DO NOT change your therapy based on one individual value recorded in
®
Comfort Curve
ACCU-CHEK
memory.
ACCU-CHEK Voicemate System
What you need to know
Roche Diagnostics has identified a situation that can occur no more than
once every seven days, during a ten-minute time period, which can cause an
individual blood glucose test result to be incorrectly spoken and incorrectly
recorded to your meter memory.
®
This situation can only occur from 12:00 (midnight) to 12:10 a.m., once
Comfort Curve
ACCU-CHEK
every seven days, if the time and date is set in your system. If time and
date are not set on your system this situation can occur once every seven
days at any time of day. Therefore, you MUST set the time and date on
your ACCU-CHEK Voicemate system and then NEVER use results generated
from 12:00 (midnight) to 12:10 a.m. to make any therapy adjustments.
What should you do?
1. Always have your time and date set. Your ACCU-CHEK Voicemate User’s
Manual and Audio Cassette provide instructions for setting time and date.
A representative from the ACCU-CHEK Customer Care Service Center can
also walk you through the instructions for setting time and date. You can
reach the ACCU-CHEK Customer Care Service Center 24 hours a day,
365 days a year at 1-800-858-8072.
2. Do not use values generated when the meter clock is from
12:00 (midnight) to 12:10 a.m. to make any therapy adjustments.
Technical Information
How the Test Works
Blood from your fingertip works with the chemicals in the test strip to make
a small electrical current in the test strip. Your meter reads the current and
gives you the blood sugar result.
Contents of the test strip: See other side
Performance Characteristics: See other side
Additional Information
Your Owner’s Booklet contains more information. If you need technical help,
call 1-800-858-8072, 24 hours a day, 7 days a week.
Visit our website at: www.accu-chek.com
What Happens if I Have Problems or Questions?
Call the ACCU-CHEK Customer Care Service Center 24 hours
a day, 365 days a year. Consumers: 1-800-858-8072.