BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2252120 · Received September 16, 2011

    Report

    Report Number
    2050012-2011-05322
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 19, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE PERFORMED STOP/HOME THE SYSTEM WITHOUT INCIDENT. THE FSE PRIMED THE INSTRUMENT AND OBSERVED NO ERRORS OR FLOODING DURING THE PRIMING. THE FSE COULD NOT REPRODUCE GLUCM AND EIC OVERFLOWING ISSUE. THE FSE NOTICED A LEAK FROM DEGASSER DUE TO FRACTURE MEMBRANE, AND REPLACED THE MEMBRANE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AND REPORTED THAT THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM GENERATED NUMEROUS ERRORS: "WASH CONC CANISTER DID NOT FILL IN TIME" ERROR, ILLEGAL SWITCH ERROR, AND A GLUCM TEMPERATURE ERROR, AND GLUCM AND ELECTROLYTE INJECTION CUP (EIC) OVERFLOWED. CUSTOMER ALSO STATED THAT THE DI INLET FILTER IS LEAKING SLOWLY, BUT INVESTIGATION REVEALED THAT LEAKING WAS ACTUALLY COMING FROM DEGASSER. NO ERRONEOUS PATIENT RESULTS WERE GENERATED, AND NO ONE WAS EXPOSED OR INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1