BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO-CLINICAL DIAGNOSTICS AUTOWASH 96

    MDR report key: 743188 · Received August 19, 2005

    Report

    Report Number
    1037985-2005-00003
    Event Type
    Malfunction
    Date Received
    August 19, 2005
    Date of Event
    February 1, 2005
    Report Date
    February 15, 2005
    Manufacturer
    TECAN AUSTRIA GES.M.B.H
    Product Code
    LXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INSTRUMENT REPORTEDLY STARTED SMOKING WHN THE USER PLUGGED IT IN. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO-CLINICAL DIAGNOSTICS AUTOWASH 96 96-WELL ELISA MICROWELL WASHER LXG TECAN AUSTRIA GES.M.B.H 7003007 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other