BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1140523 · Received August 28, 2008

    Report

    Report Number
    1823260-2008-06503
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE IN COAGUCHEK XS SYSTEM. REFERENCE MEDWATCH WITH A1 PT FOR SUSPECT DEVICE IN THE COAGUCHEK S SYSTEM.

    Description of Event or Problem · 1

    CALLER STATES THAT DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK S/COAGUCHEK XS RESULTS WERE OBTAINED: 1.9 INR/2.4 INR; 5.8 INR/4.4 INR. NO ACTION TAKEN ON DEVICE RESULT FOR PT 1. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Additional Manufacturer Narrative · 2

    REFERENCE MEDWATCH WITH A1 PT FOR SUSPECT DEVICE IN THE COAGUCHEK S SYSTEM.

    Description of Event or Problem · 2

    MEDICAL HISTORY: CHEMOTHERAPY PT, HEMATOCRIT 37.3% IN 2008. MEDICATIONS: COUMADIN. PT'S MEDICATION WAS DISCONTINUED, DUE TO THE 5.8 INR RESULT. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIPS-GJS GJS ROCHE DIAGNOSTICS 20163431

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR
    2