TP-01142
12/02/20
CoaguChek
®
Patients
CoaguChek XS Meters for Patient Self-Testing Use (CoaguChek XS PST) —
Possible Misinterpretation of Displayed Measuring Units
This Urgent Medical Device Correction (UMDC)
only
affects patients using:
Product
CoaguChek XS meter
If you are currently using the CoaguChek Vantus meter, please DISREGARD this
document.
n
The CoaguChek XS PT test strips are not affected by this issue.
Issue ____________________________________________________________________
You are receiving this Urgent Medical Device Correction (UMDC) because records indicate
that you were shipped a CoaguChek XS PST meter. This document provides important
information about your meter.
Please read this entire document.
n
The CoaguChek XS PST meter is provided to U.S. customers pre-set to the
measuring unit INR. There are two additional measuring units on the
meter: %Quick (%Q) and Seconds (Sec). In the U.S., the most accepted
unit of measure is INR. Unless your physician has instructed you to
monitor in a unit other than INR, results should be reported in INR.
Roche has been made aware of the following issues:
• The measuring unit of some patient CoaguChek XS PST meters was inadvertently changed
by the operator during use from INR to %Quick or Seconds, resulting in a CoaguChek XS
test result perceived to be different from the laboratory result in INR.
• A value displayed in %Quick or Seconds was misinterpreted by a patient as an INR result,
and the misinterpreted result was significantly higher than the patient’s actual INR.
• In the above instances, the result produced in %Quick or Seconds was not alleged to
be inaccurate.
CoaguChek XS PST
over...
URGENT MEDICAL DEVICE CORRECTION
Roche Diagnostics
Corporation
9115 Hague Road
PO Box 50457
Indianapolis, IN 46250-0457
USA
