BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 5062091 · Received September 8, 2015

    Report

    Report Number
    2050012-2015-00341
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    August 19, 2015
    Report Date
    August 19, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K103842
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT AND FOUND THE WASH VALVE ON THE BUBBLE GENERATOR ASSEMBLY WAS LEAKING. THE FSE REPLACED THE BUBBLE GENERATOR ASSEMBLY TO RESOLVE THE ISSUE, NO FURTHER LEAKING OR INSTRUMENT ERRORS WERE OBSERVED. THE INSTRUMENT SOFTWARE VERSION IS 5.4.

    Description of Event or Problem · 1

    THE CUSTOMER'S UNICEL DXC 600 SYNCHRON SYSTEM GENERATED ONE LOW ERRONEOUS CR-S (CREATININE) PATIENT RESULT. THE CR-S ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY, HOWEVER THE RESULT WAS RERUN AND AMENDED WITH NO IMPACT TO PATIENT TREATMENT. THE CUSTOMER ALSO STATED THE INSTRUMENT GENERATED SUPPRESSED (NO RESULT VALUE) QC (QUALITY CONTROL) AND RECOVERY ERRORS FOR COCM (COCAINE METABOLITE), ALT (ALANINE AMINOTRANSFERASE), BUN (BLOOD UREA NITROGEN) AND FOUND FLUID UNDER THE REAGENT PROBE DRIP TRAY. THE CUSTOMER STATED THE FLUID WAS CONTAINED AND DESCRIBED THE VOLUME AS APPROXIMATELY LESS THAN 1 CC. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592574 UNICEL DXC 600 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR