BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2101143 · Received May 24, 2011

    Report

    Report Number
    2050012-2011-01894
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. IT IS UNKNOWN IF QC WAS RUN AFTER THE EVENT PRIOR TO RE-CALIBRATION. THE CUSTOMER REPLACED NA ELECTRODE AND CO2 MEASURING ELECTRODE MEMBRANE. NA PERFORMANCE WAS ACCEPTABLE, BUT ANION GAPS WERE STILL INTERMITTENTLY LOW, SO THE CUSTOMER CHANGED THE CL ELECTRODE. AFTER CHANGING THE CL ELECTRODE, THE CUSTOMER NOTED THAT NA RECOVERY WAS THEN HIGHER ON DXC 600 THAN ON THE DIFFERENT INSTRUMENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE INSPECTED THE ISE ASSEMBLY AND NO ABNORMALITIES WERE NOTED. THE FSE REMOVED AND DISASSEMBLED FLOW-CELL. THE FSE FOUND CO2 MEMBRANE PIECES WERE ASSEMBLED ON THE ELECTRODE IN THE REVERSE ORDER. THE FSE INFORMED CUSTOMER THAT QUAD RING SIDE ALWAYS GOES TOWARD THE FLOW-CELL. THE FSE CLEANED FLOW-CELL AND REASSEMBLED, REPLACED CARBON BRIDGE AND VERIFIED PERFORMANCE. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THE UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM GENERATED SLIGHTLY LOW SODIUM RESULTS. BECAUSE THE ANION GAP RESULTS WERE LOW, THE RESULTS WERE NOT REPORTED OUT OF THE LAB. THE SPECIMENS WERE REPEATED ON A DIFFERENT INSTRUMENT WITH HIGHER NA RESULTS. RECALIBRATING THE DXC 600 INSTRUMENT GAVE HIGHER NA RESULTS, BETTER MATCHING THE DIFFERENT INSTRUMENT. PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1