BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECAN GENESIS

    MDR report key: 516673 · Received March 5, 2004

    Report

    Report Number
    MW1031453
    Event Type
    Malfunction
    Date Received
    March 5, 2004
    Date of Event
    February 18, 2004
    Report Date
    February 19, 2004
    Manufacturer
    TECAN USA
    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 CUSTOMER CALLED TO REPORT THAT THERE WAS A MISASSOCIATION OF THE SUSPECT DEVICE FRONT END ACCESSION NUMBERS WITH THE PLATE READ OUT RESULTS FROM THE DEVICE'S BACK END INSTRUMENT. THE FACILITY DID REPORT OUT RESULTS FROM RUNS WITH KNOWN ACCESSION NUMBERS OF PTS, BUT DID NOT ACT UPON THOSE RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other