BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLQUEST PRO SW

    MDR report key: 906344 · Received August 31, 2007

    Report

    Report Number
    2916837-2007-00003
    Event Type
    Malfunction
    Date Received
    August 31, 2007
    Date of Event
    August 2, 2007
    Report Date
    August 31, 2007
    Manufacturer
    BD BIOSCIENCES
    Product Code
    GKZ
    PMA / PMN Number
    K946055
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG #'S: 343926, 339455, 343928, 347527, 347526. DURING OUR ANALYSIS, WE DETERMINED THAT AN EXPERIENCED USER WOULD CATCH THIS EVENT, BUT WE ARE REPORTING BASED ON THE POTENTIAL FOR AN INEXPERIENCED USER TO MISS THIS ERROR. DESCRIPTION OF POTENTIAL MALFUNCTION: SUMMARY: IF THE CUSTOMER DELETES A GATE AND WANTS TO BRING IT BACK, WHEN THEY USE THE UNDO FEATURE, THE STATISTICS VIEW IS REORDERED AND RESULTS WERE MISMATCHED. THIS BUG ONLY AFFECTS SAMPLES BEING ANALYZED IN CELLQUEST PRO. CORRECTIVE ACTION: A CUSTOMER LETTER WILL BE SENT TO NOTIFY CUSTOMERS THAT THEY SHOULD NOT UNDO A GATE AFTER IT WAS DELETED. A SOFTWARE UPGRADE IS UNDER DEVELOPEMENT AND WILL BE SENT TO CUSTOMER'S FREE-OF CHARGE WHEN COMPLETED.

    Description of Event or Problem · 1

    CELLQUEST PRO IS A SOFTWARE PROGRAM THAT ALLOWS THE USER TO ACQUIRE AND ANALYZE DATA FROM A FLOW CUSTOMER. THE POTENTIAL MALFUNCTION COULD OCCUR FOR CUSTOMERS THAT HAVE A VERSION OF 6.0 MACINTEL COMPUTER ON A FACSCALIBUR OF FACSCAN WITH A FACSTATION OSX OPERATING SYSTEM VERSION 5.2 AND LATER, AND CELLQUEST PRO SW VERSION 4.0.2 AND LATER. IF THE CUSTOMER UTILIZES THE UNDO FEATURE TO BRING BACK A GATE THAT WAS DELETED, THE INFORMATION THAT COMES BACK ON THE STATICS VIEW WILL BE FROM A DIFFERENT REGION. THIS BUG AFFECTS ONLY SAMPLES BEING ANALYZED IN CELLQUEST PRO SOFTWARE. RESULT: IF THE CUSTOMER UTILIZES THE UNDO FEATURE TO BRING BACK A GATE THAT WAS DELETED THE GATE INFORMATION THAT COMES BACK ON THE STATISTICS VIEW WILL BE FROM A DIFFERENT REGION. THE BUG AFFECTS ONLY SAMPLES BEING ANALYZED IN CELLQUEST PRO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELLQUEST PRO SW CELLQUEST PRO SW VER 4.0.2 AND LATER GKZ BD BIOSCIENCES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR