TP-01142
page 2 of 5
Issue, continued _________________________________________________________
The current User Manual for your meter does not contain instructions on how to change
measuring units on the CoaguChek XS PST meter. This UMDC provides instructions on how
to ensure your meter is displaying INR results. Roche is updating the User Manual and the
package insert labeling for the test strips accordingly.
Actions Required
• When testing for INR,
always confirm that “INR” is displayed next to the result after
each test.
Reporting your result in a measuring unit other than INR could lead to an
incorrect assessment of appropriate treatment and potential for harm.
• Follow the instructions provided in the
Patient Instructions
section of this UMDC to
ensure that the measuring unit result is set to INR. Refer to these instructions when
adjusting the date/time in your meter and when the measuring unit needs to be reset to INR.
Any measurement unit set-up choices other than INR must be authorized by your doctor.
• If your meter is displaying a result in a different unit than INR and you are unable to reset
the measuring unit to INR after following the instructions in the
Patient Instructions
section of this UMDC, contact the
Roche Customer Support Center at 1-800-428-4674
for assistance.
• This Urgent Medical Device Correction (UMDC) serves as supplemental labeling. File this
UMDC with your User Manual for future reference.
Patient Instructions ______________________________________________________
Check the Measuring Unit for Your INR Test Result
n
The current result can be changed to a different unit without actually
changing the settings for measuring units on the meter.
1. With the meter powered off, press the
M
button and confirm your last test result is
displayed as“
INR
.”
the measuring unit is displayed next to the result
2. Press the
M
button again to confirm the previous test result also displays as“
INR
.”
