BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2150005 · Received July 5, 2011

    Report

    Report Number
    2050012-2011-02834
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND LIQUID DRIPPING FROM THE REAGENT PROBES. FSE REPLACED THE T-VALVE AND 4-WAY VALVE FOR THE REAGENT PROBES AND REAGENT SYRINGE ASSEMBLY (DUE TO LOOSE SCREW BAND ON THE BOTTOM OF THE BARREL). FSE PERFORMED PREVENTIVE MAINTENANCE (PM) AND REPLACED CARTRIDGE CHEMISTRY (CC) SAMPLE VALVE BLOCK DURING PM DUE TO VOLUME OF THE SAMPLES. FSE ALSO REPLACED LEVEL SENSE BEAD ASSEMBLY AFTER FINDING A FRAYED WIRE ON REAGENT PROBE LEVEL SENSE BEAD. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING THAT THEY OBSERVED LEAKING FROM THE REAGENT PROBE COLLAR WASH IN THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1