BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1200096 · Received October 15, 2008

    Report

    Report Number
    1823260-2008-07618
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OPERATOR NOTICED A LEAK FROM THE FRONT OF THE ANALYZER ONTO THE FLOOR WHICH WAS IMMEDIATELY WIPED UP. NO PATIENT SAMPLES WERE INVOLVED AND NO ONE WAS HARMED. THE OPERATOR FOUND THE PV 22 TUBING WAS SPLIT AND SHE CHANGED THE TUBING WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS E MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK