BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1912771 · Received December 2, 2010

    Report

    Report Number
    2050012-2010-01496
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. QC RUN AFTER THE EVENT WAS LOW.SERVICE WAS DISPATCHED AND SERVICED THE INSTRUMENT ON (B)(6) 2010.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUS ELECTROLYTE SODIUM (NA) AND CHLORIDE (CL) RESULTS THAT WERE GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER FOR THREE PATIENTS. THE INSTRUMENT GENERATED LOW NA RESULTS FOR THREE PATIENTS. THE SAMPLES WERE REPEATED AND THE RECORDS AMENDED WITH THE HIGHER RESULTS. THE CUSTOMER PROVIDED INFORMATION FOR ONLY TWO OF THE THREE PATIENTS. PATIENT TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE FALSE RESULTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1