BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1241636 · Received November 19, 2008

    Report

    Report Number
    1823260-2008-08582
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED.

    Description of Event or Problem · 1

    CALLER STATES THAT DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK S/LABORATORY RESULTS WERE OBTAINED: NO ACTION TAKEN ON DEVICE RESULTS. 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 731A-G6

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK