BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1770973 · Received November 13, 2007

    Report

    Report Number
    1823260-2007-09868
    Event Type
    Malfunction
    Date Received
    November 13, 2007
    Date of Event
    October 31, 2007
    Report Date
    November 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES, THE PATIENT TESTED 6.2 INR ON THE COAGUCHEK S SYSTEM AND >18.6 INR ON A COMPARISON LAB. NO TREATMENT INFORMATION PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIPS - JPA JPA ROCHE DIAGNOSTICS 563A-E6

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK