BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON CLINICAL SYSTEM

    MDR report key: 2011142 · Received March 8, 2011

    Report

    Report Number
    2050012-2011-00674
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO THE EVENT, THE OPERATOR HAD PERFORMED TWICE WEEKLY MAINTENANCE AND SUBSEQUENTLY HAD PROBLEMS WITH CALIBRATION AND QC. A REVIEW OF DATA INDICATED THAT THE ISSUE OCCURRED IN CONJUNCTION WITH MAINTENANCE. AFTER THE ISSUE WAS NOTICED, THE SYSTEM WAS RE-CALIBRATED AND QC WAS WITHIN THE ESTABLISHED RANGE. IT IS NOT KNOWN IF QC WAS RUN AFTER THE EVENT PRIOR TO RECALIBRATION. BCI FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT. THE FSE NOTED THAT THE PERFORMANCE OF THE CHLORIDE ELECTRODE WAS APPROACHING REPLACEMENT CRITERIA. THE FSE REPLACED THE ELECTRODE, CLEANED THE PORT, AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW SODIUM (NA) RESULTS GENERATED BY UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM FOR 15 PATIENT SAMPLES. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY A PHYSICIAN. REPEAT TESTS WERE PERFORMED AFTER RECALIBRATION OF THE SYSTEM AND THE REPORTS WERE AMENDED. PATIENT TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE ERRONEOUS RESULTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1