BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTOMICS® FC500 FLOW CYTOMETER SYSTEM

    MDR report key: 3493336 · Received November 27, 2013

    Report

    Report Number
    1061932-2013-02655
    Event Type
    Malfunction
    Date Received
    November 27, 2013
    Date of Event
    November 7, 2013
    Report Date
    November 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K030828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THAT THIS PART FAILED BY BECOMING UNSTABLE AND SHOWING DRIFT IN THE OUTPUT SIGNAL. THIS FAILURE MODE HAS THE POTENTIAL TO CAUSE ERRONEOUS RESULTS IF THE DRIFT IN THE OUTPUT SIGNAL GOES UNDETECTED BY THE OPERATOR. HOWEVER, THIS FAILURE MODE WOULD BE READILY DETECTED BY THE OPERATOR WHEN RUNNING STARTUP QC PROCEDURES. QC WOULD FAIL SPECIFICATIONS. THE ANALYTES POTENTIALLY AFFECTED ARE DEPENDENT ON THE CONFIGURATION SELECTED BY THE OPERATOR AND MAY INCLUDE CD3, CD4, CD8, CD19, CD34, CD45, AND CD56. (B)(4).

    Description of Event or Problem · 1

    A FIELD SERVICE ENGINEER (FSE) REPORTED PREMATURE FAILURE OF A HV DAC CARD AFTER 12 HOURS IN THE CUSTOMER'S FLOW CYTOMETER INSTRUMENT. THE FSE RESOLVED THE ISSUE BY REPLACING IT WITH A NEW AND IDENTICAL PART. NO ERRONEOUS PATIENT RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620664 CYTOMICS® FC500 FLOW CYTOMETER SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER TN, FC500 FLOW CYTOMETER 100-240V, 50/60HZ NA

    Patients

    Seq Age Sex Outcome Treatment
    1