# 370 / 2007 - RB-874

CoaguChek

PT Test

®

XS

US

REF 0 4625374160

6 Test Strips REF 0 4499603001 and 1 Code Chip

PERSONAL USE

Purpose

The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek

XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin ® or warfarin.

The CoaguChek XS System uses blood from a fingerstick. The system is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor. Users should be stabilized on anticoagulation medications such as Coumadin or warfarin prior to selftesting with the CoaguChek XS System.

Caution: These test strips are for use outside the body only. Do not eat the test strips.

Before You Start Testing

If you are new to the CoaguChek XS System, watch the CoaguChek XS System DVD and read the CoaguChek XS System Getting Started

Guide before testing.

Storing the Test Strips

Store the test strips in their container, with the cap closed. You can store the test strips at room temperature or in the refrigerator

(2 to 30°C or 36 to 86°F). When stored properly, the test strips can be used until the expiration date printed on the test strip strip container.

Throw the test strips away if they are past their “Use By” date.

Handling the Test Strips

When you are ready to test, remove 1 test strip from the container. Close the container tightly.

You must use the test strip within 10 minutes of removing it from the container. Otherwise, you may get an error message and you will have to repeat the test.

Step 1: Getting Ready to Test

Gather supplies:

● CoaguChek XS Meter

● Container of CoaguChek XS PT Test Strips

● Test Strip Code Chip

● ACCU-CHEK

Lancet

® Softclix Lancet Device and

Put the meter on a flat surface, like a table or countertop, that will not vibrate or move during testing. Movement can result in an error message.

If you are using test strips from a new, unopened box, you will need to change the test strip code chip. The 3-number code on the test strip container must match the 3number code on the code chip. To install the code chip, follow the instructions in the Code

Chip section of the CoaguChek XS System

User Manual.

Step 2: Testing Blood from a Fingerstick

Getting a Good Drop of Blood

Increasing the blood flow in your finger will help you get a good drop of blood. Before you lance your finger, try the following techniques until you see that your fingertip has good color:

● Warm your hand by holding it under your arm, using a hand warmer, and/or washing your hand with warm water.

● Hold your arm down to the side so that your hand is below your waist.

● Massage your finger from its base.

● If needed, immediately after lancing, gently squeeze your finger from its base to encourage blood flow.

Procedure

1. Wash your hands with warm, soapy water.

Dry completely.

2. Take a test strip out of the container. Close the container tightly.

3. Insert a test strip as far as you can into the meter. The meter turns on.

4. Confirm that the number displayed matches the number on the test strip container, then press M. If the numbers are different, make sure you are using the code chip that came with the test strips you are using. If they still do not match, call the Roche Diagnostics Technical Service

Center at 1-800-428-4674, 24 hours a day,

7 days a week, 365 days a year.

6. When the meter is warmed up, a flashing test strip and blood drop symbol appear and the meter begins a countdown. You have 120 seconds to apply blood to the test strip.

7. Use the lancet device to perform a fingerstick. Set the penetration depth to 5. See the CoaguChek XS System User

Manual for more information. After sticking your finger, you have 15 seconds to apply blood to the test strip. If it takes longer to form a good drop of blood, lance a different finger for the test.

9. You’ll see the hourglass when the blood test begins. Then, pull your finger away from the test strip.

10. Record the result on the CoaguChek XS

System Prothrombin Time Self-Testing Log

Book. Call your doctor with the test result.

11. Properly dispose of the used lancet and test strip.

12. Turn the meter off.

If you need to redo a test, use a new lancet, a new test strip, and a different finger.

Additional Information

The CoaguChek XS System User Manual contains more information. If you need technical help, call the Roche Diagnostics Technical

Service Center at 1-800-428-4674, 24 hours a day, 7 days a week, 365 days a year.

Very Low or Very High Test Results

The CoaguChek XS PT test strips provide test results if the INR value is between 0.8 and

8.0. If the meter displays < (less than) 0.8 or

> (greater than) 8.0, repeat the test. If, when you repeat the test, you get the same display

(either < 0.8 or > 8.0), call your doctor.

5. An hourglass appears as the meter warms up, which takes about 30 seconds.

8. The meter must be on a table. Apply 1 drop of blood to the side of the test strip.

It’s important to hold the blood drop to

the test strip until you hear a beep.

Remember to apply only one drop of blood—don’t add more. Do not touch or remove the test strip when a test is in progress.

The result appears in about 1 minute.

OR

0 4899954001(03)

V1/R1 (black) – 2007-03

# 370 / 2007 - RB-874

Error Messages

If you see Error 7, this means the meter was unable to detect a clot. Repeat the test. Be sure to carefully follow the steps on the previous pages. For example, make sure the fingertip is thoroughly dry, use the meter on a surface free of vibrations, and apply the blood drop within

15 seconds of sticking the fingertip. If you still get Error 7, call your doctor immediately to arrange for testing using another method. If the meter displays any other error message, refer to the Error Messages section of the

CoaguChek XS System User Manual.

Built-In Controls

The CoaguChek XS System has built-in quality control functions in the meter and test strips.

The meter automatically runs its own quality control test as part of every blood test, so you never have to run quality control tests with liquid quality controls. For more information about the built-in quality control functions, see the CoaguChek XS System User Manual.

Performance Characteristics

Measuring Range: The CoaguChek XS PT

System has a PT measuring range of 0.8–8.0

INR and 9.6–96.0 seconds.

Accuracy: A study was conducted comparing test results obtained by trained users with those obtained by healthcare professionals, when both were using the CoaguChek XS

System. The correlation was very good, as indicated by the following statistics: N=463,

Slope=1.000, Intercept=0.0 and Correlation

Coefficient=0.977. This study shows that trained users are able to obtain results that are as accurate as those obtained by healthcare professionals trained in the use of the CoaguChek XS System.

The test results obtained by trained users were also compared to results obtained using a laboratory-based reference method. Results are shown in the plot below.

Study User Demographics: A clinical study was conducted by Roche Diagnostics, consisting of four visits to the clinical site. Informed consent and randomization occurred at Visit 1. Testing began at Visit 2.

Ninety-one patients completed at least one visit after Visit 1. The following table outlines the demographic information for the trained users who completed at least one visit after

Visit 1.

Demographic

Total number of users

Caregivers

Males

Females

Age range

Mean Age

Age 65 – 69 years

Age 70 – 74 years

Number Percent

91 100%

4

51

4.4%

56%

40 44%

32 – 89 100%

64 years N/A

16 17.6%

13 14.3%

Age 75 years and up

Education Level-

Eighth grade or less through advanced college degree

16

91

17.6%

100%

Median Education Level Some college N/A

On warfarin 3 – 12 months 19 20.9%

On warfarin 1 – 2 years 22

On warfarin 3 – 5 years 23

On warfarin > 5 years

Atrial fibrillation

27

38

24.2%

25.3%

29.7%

41.8%

Valve replacement 25

Stroke/stroke prevention 7

DVT

Other heart conditions

5

6

Other clotting disorders 10

27.5%

7.7%

5.5%

6.6%

11%

There were 107 patients enrolled. A total of 88 patients completed all four visits to the site.

The reasons for drop-outs were as follows:

Reason for Drop-Out

Felt it was too stressful

Didn’t have time

Didn’t want to use meter on his own

Didn’t think he could learn to use meter

Was having knee surgery

Study terminated prior to Visit 4

Unknown

Disqualified due to target INR range outside of study protocol

# of Subjects

2

3

1

1

1

1

7

3

Precision: A study was conducted and the precision of duplicates for capillary blood results was calculated for both trained users and healthcare professionals. The following results were obtained:

N

Mean

SD

CV

User

Results

214

2.57

0.13

5.13

Professional

Results

249

2.52

0.13

5.36

This study shows that trained users are able to obtain results that are as precise as those obtained by healthcare professionals trained in the use of the CoaguChek XS System.

Limited Warranty

Roche Diagnostics warrants that your

CoaguChek XS PT test strips will be free from defects in materials and workmanship until the product expiration date printed on the label if the test strips are stored and used in the manner described in this package insert and in your CoaguChek XS System User

Manual.

If, prior to the expiration date of the test strips, there is a defect in materials or workmanship,

Roche Diagnostics will replace the test strips free of charge. Your sole and exclusive remedy with respect to the strips shall be replacement.

Any warranty claim should be directed to the

Roche Diagnostics Technical Service Center at 1-800-428-4674.

THE ABOVE WARRANTY IS EXCLUSIVE

OF ALL OTHER WARRANTIES, AND

ROCHE DIAGNOSTICS MAKES NO

OTHER WARRANTIES, EXPRESS OR

IMPLIED, INCLUDING WITHOUT

LIMITATION THE IMPLIED WARRANTY OF

MERCHANTABILITY OR FITNESS FOR

A PARTICULAR PURPOSE. IN NO EVENT

SHALL ROCHE DIAGNOSTICS BE

LIABLE TO THE PURCHASER OR ANY

OTHER PERSON FOR ANY INCIDENTAL,

CONSEQUENTIAL, INDIRECT, SPECIAL

OR PUNITIVE DAMAGES ARISING FROM

OR IN ANY WAY CONNECTED WITH THE

PURCHASE OR USE OF THE TEST STRIPS.

NO WARRANTY OF MERCHANTABILITY OR

FITNESS FOR A PARTICULAR PURPOSE,

IF ANY IS IMPLIED FOR THE SALE OF

THE TEST STRIPS, SHALL EXTEND

FOR A LONGER DURATION THAN THE

EXPIRATION DATE OF THE TEST STRIPS.

The following U.S. patents have been granted or are pending for the CoaguChek XS System (meter and test strips): 6,662,439;

7,073,246; 2005/0103624; 6,881,378; 6,207,000; 2005/0214171;

2005/0123441; 6,645,368; 2004/0157339; 2005/0129574;

2005/0135968.

COAGUCHEK, ACCU-CHEK and SOFTCLIX are trademarks of Roche.

All other product names and trademarks are the property of their respective owners.

Manufactured by:

"

Roche Diagnostics GmbH

D-68298 Mannheim www.roche.com

www.coaguchek.com

Distributed in the U.S.A. by:

Roche Diagnostics

9115 Hague Road

Indianapolis, IN 46256

©2007 Roche Diagnostics.

All rights reserved.

Made in Germany

0 4899954001(03)

R1 (black)