BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTOMICS FC 500 MPL FLOW CYTOMETER

    MDR report key: 2600048 · Received June 6, 2012

    Report

    Report Number
    1061932-2012-01821
    Event Type
    Malfunction
    Date Received
    June 6, 2012
    Date of Event
    May 11, 2012
    Report Date
    May 11, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K071681
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT THE PROBE VALVE SWITCH OF THE CYTOMICS FC 500 MPL FLOW CYTOMETER LEAKED LIQUID. THERE WAS NO REPORT OF PATIENT RESULTS AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE PROBE SWITCH VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYTOMICS FC 500 MPL FLOW CYTOMETER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1