BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2268290 · Received September 28, 2011

    Report

    Report Number
    2050012-2011-05630
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Date of Event
    September 3, 2011
    Report Date
    September 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011 AND FOUND FOREIGN DEBRIS CLOGGING THE ISE DRAIN VALVE. FSE CLEANED THE VALVE AND VERIFIED PERFORMANCE ACCORDING TO ESTABLISHED PROCEDURES. FSE ALSO ENCOUNTERED INTERMITTENT REAGENT LEVEL SENSE ERROR WHILE TROUBLESHOOTING AND PROCEEDED TO REPLACE AND ALLIGN PROBE A LEVEL SENSE BEAD. INSTRUMENT REPAIRS WERE AGAIN VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED REPORTING OF AN ERRONEOUS ION SELECTIVE ELECTRODES (ISE) RESULT GENERATED FROM A UNICEL DXC 600 SYNCHRON SYSTEM ON (B)(6) 2011. CUSTOMER INDICATED THAT THE ISE MODULE IS A POST ISE MODIFICATION MODULE. CUSTOMER REPORTED THAT THE INSTRUMENT GENERATED A FALSE HIGH NA , A FALSE LOW CL AND A SUPPRESSED CALC RESULTS FOR ONE PATIENT SAMPLE WHILE K AND CO2 RESULTS WERE NOT AFFECTED. CUSTOMER STATED THAT THE PATIENT'S SAMPLE HAS BEEN RUN ON ANOTHER INSTRUMENT (UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM) AND THE ORIGINAL RESULTS WERE AMENDED. INSTRUMENT PRINTOUTS INDICATED THAT THE ORIGINAL INSTRUMENT IN QUESTION GENERATED A RESULT OF 154 MMOL/L OF NA, 76 MMOL/L OF CL AND A SUPPRESSED CALC RESULT DUE TO A CALIBRATION REFERENCE DRIFT. THE REPEAT ON ANOTHER INSTRUMENT (DXC 600I) GAVE A RESULT OF 139 MMOL/L OF NA, 104 MMOL/L OF CL AND 8.6 MG/DL OF CALC. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1