BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2080779 · Received May 6, 2011

    Report

    Report Number
    2050012-2011-01492
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. AFTER THE EVENT OCCURRED QC WAS LOW. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE ELECTROLYTE INJECTION CUP (EIC) WASTE VALVE, WHICH RESOLVED THE ISSUE. PERFORMANCE WAS ALSO VERIFIED BY THE FSE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY LOW SODIUM (NA), CHLORIDE (CL), AND CALCIUM (CA) RESULTS THAT WERE GENERATED BY THE UNICEL DXC 600 SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE REVIEWED BY THE CUSTOMER AND WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AFTER THE SYSTEM WAS RECALIBRATED. THE RESULTS WERE HIGHER AND WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER COULD NOT PROVIDE ACTUAL RESULTS OR HOW MANY SAMPLES WERE AFFECTED, BUT PROVIDED ONE (1) EXAMPLE OF THE ERRONEOUS RESULTS. PER THE CUSTOMER, NA ORIGINALLY RECOVERED 133 MMOL/L, AND UPON REPEAT, RECOVERED 140 MMOL/L. CA ORIGINALLY WAS 8.1 MG/DL, AND UPON REPEAT WAS 9.0 MG/DL (THE DIFFERENCE IN RESULTS IS WITHIN THE PRECISION OF THE ASSAY). THE CUSTOMER DID NOT PROVIDE ANY CL EXAMPLES, BUT STATED THAT THE MAGNITUDE OF SHIFT WAS SIMILAR TO NA AND CA. THERE WAS NO AFFECT TO PATIENT TREATMENT IN THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1