BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTISET SOFTWARE VERSION 2.1 AND LATER

    MDR report key: 920770 · Received September 28, 2007

    Report

    Report Number
    2916837-2007-00004
    Event Type
    Malfunction
    Date Received
    September 28, 2007
    Date of Event
    August 2, 2007
    Report Date
    August 31, 2007
    Manufacturer
    BD BIOSCIENCES
    Product Code
    GKZ
    PMA / PMN Number
    K963963
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING OUR ANALYSIS, WE DETERMINED THAT AN EXPERIENCED USER WOULD CATCH THIS EVENT, HOWEVER WE ARE REPORTING THIS EVENT BASED ON THE POTENTIAL FOR AN INEXPERIENCED USER TO MISS THIS ERROR. DESCRIPTION OF MALFUNCTION: SUMMARY: IF THE CUSTOMER PERFORMS GATING ADJUSTMENTS OTHER THAN HOW IT IS DESCRIBED IN THE MANUAL, THE STATISTICS WILL NOT MATCH THE ADJUSTED GATING. DETAILS: IF THE GATING IS ADJUSTED ONLY WHILE IN LAB REPORT VIEW, AND NOT BY SELECTING THE MANUAL ADJUST BUTTON, THE STATISTICS WILL NOT BE UPDATED TO REFLECT THE NEW GATE. CORRECTION ACTION: A CUSTOMER LETTER WILL BE SENT TO NOTIFY CUSTOMERS THAT THEY SHOULD FOLLOW PRESCRIBED METHODS IN THE USER'S MANUAL FOR MAKING CHANGES TO GATES. IF OTHER METHODS ARE USED TO MAKE CHANGES TO THE GATES, THE LAB REPORT WOULD NOT HAVE UPDATED THE STATISTICS. A SOFTWARE UPGRADE IS UNDER DEVELOPMENT AND WILL BE SENT TO CUSTOMER'S FREE-OF-CHARGE WHEN COMPLETE.

    Description of Event or Problem · 1

    DESCRIPTION: MULTISET IS A SOFTWARE PROGRAM THAT IS INSTALLED ON A FACSCALIBUR FLOW CYTOMETER. THE POTENTIAL MALFUNCTION COULD OCCUR FOR CUSTOMERS THAT HAVE A FACSCALIBUR WITH AN OS10 OPERATING SYSTEM AND MULTISET SOFTWARE VERSIONS 2.1 AND LATER, AND DO NOT FOLLOW THE PRESCRIBED METHOD IN THE USER'S MANUAL FOR MAKING GATING ADJUSTMENTS. IF THE GATING IS ADJUSTED ONLY WHILE IN THE LAB REPORT VIEW, AND NOT BY SELECTING THE MANUAL ADJUST BUTTON, THE STATISTICS WILL NOT BE UPDATED TO REFLECT THE ADJUSTED GATING. RESULT: IF A CUSTOMER PERFORMS A GATING ADJUSTMENT OTHER THAN HOW IT IS DESCRIBED IN THE MANUAL, THE STATISTICS DISPLAYED IN THE LAB REPORT VIEW WOULD NOT MATCH THE NEW ADJUSTED GATING. IT WILL DISPLAY THE CHANGED GATES WITH THE ORIGINAL (NOW INCORRECT) STATISTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTISET SOFTWARE VERSION 2.1 AND LATER MULTISET GKZ BD BIOSCIENCES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR