BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECAN GENESIS

    MDR report key: 516672 · Received March 5, 2004

    Report

    Report Number
    MW1031454
    Event Type
    Malfunction
    Date Received
    March 5, 2004
    Date of Event
    March 2, 2004
    Report Date
    March 2, 2004
    Manufacturer
    TECAN US
    Product Code
    LXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT WAS VISUALLY CHECKING THE AMPLIFICATION AND REACTION PLATE NUMBERS AND REALIZED THAT THE WRONG AMPLIFICATION PLATE NUMBER HAD BEEN TIED TO A THIRD INTERNAL CONTROL REACTION PLATE. THE ACCOUNT MANUALLY VERIFIED THE CORRECT PT ID'S AND REPORTED THE RESULTS OUT CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECAN GENESIS GENERAL PURPOSE LABORATORY INSTRUMENT LXG TECAN US 10-150 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other