BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 PRO SYNCHRON SYSTEM

    MDR report key: 3951469 · Received July 22, 2014

    Report

    Report Number
    2050012-2014-00356
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE DETERMINED THE SOURCE OF THE LEAK WAS FROM THE EIC (ELECTROLYTE INJECTION CUP). THE FSE REPLACED A DEFECTIVE EIC VALVE TO RESOLVE THE ISSUE, NO FURTHER LEAKING WAS OBSERVED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM THE MC (MODULE CHEMISTRY) SAMPLE PROBE ON A UNICEL DXC 800 PRO SYNCHRON SYSTEM. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED. A BECKMAN FIELD SERVICE ENGINEER WAS DISPATCHED AND DETERMINED THE SOURCE OF THE LEAK WAS FROM THE EIC (ELECTRODE INJECTION CUP) INSTEAD OF THE INITIALLY REPORTED MC SAMPLE PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428780 UNICEL DXC 800 PRO SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1