BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 4131298 · Received October 1, 2014

    Report

    Report Number
    2050012-2014-00453
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT AND CONFIRMED A LEAK FROM REAGENT PROBE B. THE FSE REPLACED THE REAGENT PROBE B WASH COLLAR VALVE (SOLENOID VALVE) TO RESOLVE THE ISSUE, NO FURTHER LEAKING WAS OBSERVED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WATER CONDENSATION BUILD UP IN THE REAGENT CAROUSEL COMPARTMENT ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER STATED THE FLUID WAS CONTAINED TO THE INSTRUMENT AND A SERVICE REQUEST WAS INITIATED. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611877 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1