BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACSDIVA 5.0.1

    MDR report key: 881102 · Received April 18, 2007

    Report

    Report Number
    2916837-2007-00002
    Event Type
    Malfunction
    Date Received
    April 18, 2007
    Date of Event
    February 14, 2007
    Report Date
    April 18, 2007
    Manufacturer
    BD BIOSCIENCES
    Product Code
    GKZ
    PMA / PMN Number
    K040725
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, ROOT CAUSE, AND CORRECTION. ROOT CAUSE: SOFTWARE IMPLANTATION ERROR. CORRECTIVE ACTION: SEND A CUSTOMER LETTER TO NOTIFY THE CUSTOMERS OF THE PROBLEM AND TO PROVIDE A WORK AROUND. WORK AROUND INSTRUCTIONS INCLUDE: "IN ORDER TO AVOID THIS PROBLEM, EACH TUBE OR WELL SHOULD BE ASSIGNED AT LEAST TWO FLUORESCENCE PARAMETERS BEFORE EXPORTING FCS 3.0 DATA FILES. IN ADDITION, MANUALLY EXPORTING TUBES OR WELLS AT ONE TIME WILL PREVENT THE PROBLEM FROM OCCURRING". REWORK INSTRUCTIONS WILL BE CREATED IN ORDER TO ADD THE LETTER TO THE SOFTWARE KIT. A SERVICE BULLETIN WILL BE GENERATED TO INFORM THE PHONE SERVICE/CALL CENTER WHAT TO DO. THE ANOMALY WILL BE FIXED IN A NEW VERSION OF SOFTWARE. THIS INFORMATION CONSTITUTES THE INITIAL AND FINAL REPORT. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    SUMMARY: (RECEIVED 2/14/07, ISSUE VERIFIED 3/20/07) THIS ANOMALY AFFECTS EXPORTED DATA FROM HOMEBREW/LAB DEVELOPED ASSAYS IN WHICH DATA FROM A FILE CONTAINING ONE OR NO FLUORESCENCE PARAMETERS IS EXPORTED. DATA CAN BE EXPORTED MANUALLY OR BY USING THE AUTO EXPORT FEATURE. THIS ANOMALY WILL OCCUR UNTIL THE SOFTWARE IS RESTARTED. THE ORIGINAL DATA FILES WITHIN THE BD FACSDIVA DATABASE ARE NOT AFFECTED. BD DIAGNOSTIC ASSAYS ARE NOT AFFECTED. NO RESULTS WERE REPORTED OUT OF THE LAB. DETAILS: THE EVENT OCCURS WHEN A DATA FILE CONTAINING ONE OR NO FLUORESCENCE PARAMETERS IS EXPORTED. THE SOFTWARE WILL THEN AUTOMATICALLY APPLY COMPENSATION TO THE FILE AND ALL SUBSEQUENTLY EXPORTED FILES, EVEN IF THE ORIGINAL FILE DID NOT HAVE COMPENSATION APPLIED. THIS PROBLEM WILL OCCUR IF MANUALLY EXPORT MULTIPLE TUBES OR WELLS, A SPECIMEN, OR AN EXPERIMENT, OR WHEN USE THE AUTO-EXPORT FEATURE, AND WILL CONTINUE UNTIL THE SOFTWARE IS RESTARTED. WHEN THESE EXPORTED DATA FILES ARE IMPORTED AND REANALYZED, THEY MAY DISPLAY INCORRECT RESULTS. THE ORIGINAL DATA FILES ARE NOT AFFECTED WITHIN THE BD FACSDIVA DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FACSDIVA 5.0.1 BD FACSDIVA GKZ BD BIOSCIENCES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other