BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSDIVA VERSION 6.0 AND 6.1

    MDR report key: 971264 · Received December 21, 2007

    Report

    Report Number
    2916837-2007-00005
    Event Type
    Malfunction
    Date Received
    December 21, 2007
    Date of Event
    November 27, 2007
    Report Date
    December 21, 2007
    Manufacturer
    BD BIOSCIENCES
    Product Code
    GKZ
    PMA / PMN Number
    K040725
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, ROOT CAUSE, AND CORRECTION. ROOT CAUSE: IN DIVA SOFTWARE VERSION 6.0 OR 6.1 THE STATISTICS VIEW UPDATE IS DONE USING DIFFERENT THREADS AND ON THE SYSTEM BECAUSE THE SYSTEM USES TWO PROCESSORS. THE UPDATES TO THE VIEW BY THESE DIFFERENT THREADS CAN GET INTO A CONDITION WHERE INTERMITTENTLY THE VIEW MIGHT NOT GET THE COMPLETE UPDATE, AND HENCE THE STATISTICS VIEW VALUES CAN BE DIFFERENT FROM THE POPULATION HIERARCHY. WORK AROUND: THE FREQUENCY OF THIS PROBLEM WILL BE REDUCED, BUT NOT PREVENTED, BY HAVING ONE OR MORE PARAMETER STATISTICS (IE, MEAN, MEDIA, %CV, AND SD) DISPLAYED IN EACH STATISTICS VIEW. IN ORDER TO DETERMINE IF THE STATISTICS HAVE BEEN IMPACTED, USERS WILL BE INSTRUCTED TO RELOAD DATA BY CLOSING AND REOPENING AN EXPERIMENT BEFORE REPORTING RESULTS. CORRECTION: BD WILL SEND CUSTOMER LETTER AND PROVIDED A WORK AROUND TO THE USERS. BD BIOSCIENCES WILL RELEASE A VERSION OF BD FACSDIVA SOFTWARE TO CORRECT THIS PROBLEM. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY BDB THAT THE DISTRIBUTOR, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THIS PROBLEM CAN OCCUR ON BD FACSDIVA VERSIONS 6.0 AND 6.1 WHEN COMBINED WITH A SPECIFIC COMPUTER SYSTEM CONFIGURATION. THIS PROBLEM HAS NOT BEEN REPRODUCED IN OTHER COMPUTER SYSTEMS OR IN OTHER BD FACSDIVA SOFTWARE VERSIONS. THIS ISSUE WAS DISCOVERED BY A CUSTOMER. OUR INVESTIGATION DETERMINED THAT THIS ERROR OCCURS WITHIN THE FUNCTION THAT UPDATES THE RESULTS STATISTICS IN BD FACSDIVA SOFTWARE VERSION 6.0 AND 6.1 RUNNING ON THE HP XW4400 COMPUTER SYSTEM. WHEN THE GATING IS ADJUSTED, THE STATISTICS ASSOCIATED WITH THE UPDATED GATES MAY NOT BE UPDATED. THIS ERROR OCCURS WHEN GATES OR COMPENSATION IS ADJUSTED. IMPACT TO THE RESULT: SAMPLE RESULTS STATISTICS MAY NOT UPDATE WHEN GATES OR COMPENSATION ARE ADJUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD FACSDIVA VERSION 6.0 AND 6.1 BD FACSDIVA GKZ BD BIOSCIENCES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other