BEUDAMED
    FDA Adverse Event Other Summary report: N

    FC500-MPL WITH MXP SOFTWARE (VERSION 2.1)

    MDR report key: 836059 · Received October 12, 2006

    Report

    Report Number
    1061932-2006-00044
    Event Type
    Other
    Date Received
    October 12, 2006
    Date of Event
    September 15, 2006
    Report Date
    October 12, 2006
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LXG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FC500-MPL INSTRUMENT WAS PERFORMING PER DESIGN AT THE TIME OF THIS EVENT. QC WAS RUN PRIOR TO AND AFTER THE EVENT AND RESULTS WERE WITHIN SPECIFICATIONS. IT WAS DETERMINED THAT THE PROBLEM WILL OCCUR IN PROTOCOLS WHERE RATIO PARAMETER IS NECESSARY FOR RESULTS. IT WAS DETERMINED THAT THIS PROBLEM WILL BLINDLY AFFECT ALL PROTOCOLS CONTAINING THE SAME PARAMETER HIERARCHY. IF THESE PROTOCOLS ARE RUN, ERRONEOUS YET CREDIBLE RESULTS COULD BE GENERATED. BASED ON THE INVESTIGATION, BOTH VERSIONS OF THE MXP SOFTWARE (2.0 AND 2.1) ARE AFFECTED. TREATMENT DECISION WAS NOT AFFECTED IN THIS EVENT, BUT DUE TO THE POTENTIAL OF THIS EVENT TO OCCUR UNKNOWINGLY, THERE IS A POSSIBILITY THAT TREATMENT DECISION MAY BE AFFECTED.

    Description of Event or Problem · 1

    MFR APPLICATIONS SPECIALIST (AS) REPORTED A PROBLEM WHICH WAS DISCOVERED DURING AN IN-HOUSE TESTING ON THE FC500-MPL INSTRUMENT, WITH MXP SOFTWARE. WHEN RUNNING A PROTOCOL THAT CONTAINED A RATIO PARAMETER FUNCTION, THE FOLLOWING WAS OBSERVED: BY OPENING THE PARAMETER DIALOGUE BOX AND THEN CLOSING THE PARAMETERS CHOSEN FOR THE RATIO PARAMETER, IT WOULD REVERT TO THE DEFAULT VALUES. FURTHERMORE, THE ALREADY SAVED PROTOCOLS CONTAINING THE RATIO PARAMETER BEING MADE FROM THE SAME PARAMETERS WOULD BE ALSO AFFECTED. THE AS INDICATED THAT PT RESULTS WERE NOT AFFECTED IN THIS EVENT SINCE IT OCCURRED DURING AN INTERNAL TESTING, AND NO PT RESULTS WERE RELEASED AT THE TIME. THERE WAS NO DEATH OR SERIOUS INJURY REQUIRING MEDICAL ATTENTION ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FC500-MPL WITH MXP SOFTWARE (VERSION 2.1) GENERAL PURPOSE LABORATORY EQUIPMENT LABELED OR PROMOTED FOR LXG BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other