BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2853552 · Received December 3, 2012

    Report

    Report Number
    2050012-2012-01887
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: FLOWCELL CARBON BRIDGE, MODULAR CHEMISTRY (MC) COLLAR WASH AND PROBE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING LOW NA (SODIUM) RESULTS FOR 22 NEONATAL ICU (INTENSIVE CARE UNIT) PATIENT SAMPLES FROM A UNICEL DXC 600 SYNCHRON SYSTEM. THE CUSTOMER STATED THAT THE RESULTS WERE FLAGGED AND NO ERRONEOUS RESULTS WERE RELEASED OUT OF THE LAB. THE SAMPLES WERE RERUN ON AN ALTERNATE DXC IN THE LABORATORY AND THE RESULTS WERE REPORTED OUT. REVIEW OF THE CUSTOMER'S QC (QUALITY CONTROL) RUN ON THE DAY PRIOR TO THE EVENT EXHIBITED SOME IMPRECISION. HOWEVER, QC RUN ON THE DAY OF THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES AND CLOSE TO THE MEAN. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE NA (SODIUM) MEASURING AND REFERENCE ELECTRODES BUT ISSUE WAS NOT RESOLVED. FSE THEN REPLACED THE ELECTRON INJECTION CUP (EIC) VACUUM VALVE AS WELL AS THE FLOWCELL CARBON BRIDGE. THE FSE ALSO REMOVED AIR SLUGS FROM THE NA ELECTRODES AND REPLACED THE MODULAR CHEMISTRY (MC) COLLAR WASH AND PROBE. INSTRUMENT'S PERFORMANCE WAS THEN VERIFIED PER ESTABLISHED PROCEDURES. FAILURE MODE IS UNKNOWN AS MULTIPLE PARTS WERE REPLACED WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA