BEUDAMED
    FDA Adverse Event Other Summary report: N

    FC500-MPL WITH MXP SOFTWARE

    MDR report key: 745781 · Received June 28, 2005

    Report

    Report Number
    1061932-2005-00023
    Event Type
    Other
    Date Received
    June 28, 2005
    Date of Event
    May 31, 2005
    Report Date
    June 28, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LXG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM DESCRIBED IN THIS EVENT OCCURRED DURING THE INSTRUMENT INSTALLATION AND DID NOT AFFECT USER OR PATIENT. DUE TO THE POTENTIAL OF THIS EVENT TO RECUR UNKNOWINGLY FOR CD34+ PARAMETER, THERE IS A POSSIBILITY THAT TREATMENT DECISIONS MAY BE AFFECTED. A MALFUCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A PROBLEM WAS ENCOUNTED WITH THE FC500-MPL (WITH MXP SOFTWARE) INSTRUMENT. * THE FSE INDICATED THAT THE PROBLEM WAS OBSERVED DURING AN INSTRUMENT INSTALLATION WHEN THE LASER RELAY WAS TRIPPED ACCIDENTALLY CAUSING THE ARGON LASER TO SHUTDOWN. * AS OBSERVED BY THE FSE, THE LASER TO SHUTDOWN. WAS NOT DETECTED BY THE SOFTWARE; THE FAILURE WAS OT DISPLAYED ON THE STATUS BAR AND THE SOFTWARE CONTINUED TO RUN. * THE FSE INDICATED THAT NO ONE WAS EXPOSED TO THE LASER RADATION SINCE THE LASER IS TURNED OFF BY AN INTERLOCK BREACH. * THE FSE INDICATED THAT PATIENT RESULTS WERE NOT AFFECTED IN THIS EVENT SINCE THE LASER FAILURE OCCURRED DURING THE INSTRUMENT INSTALLATION, AND NO PATIENT SAMPLES WERE TESTED AT THE TIME. * THE FSE INDICATED THAT THERE WAS NO AFFECT TO THE PATIENT OR USER AS THIS EVENT OCCURRED DURING THE INSTRUMENT INSTALLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FC500-MPL WITH MXP SOFTWARE GENERAL PURPOSE LABORATORY EQUIPMENT LABELED OR PROMOTED FOR LXG BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other