BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1993840 · Received February 16, 2011

    Report

    Report Number
    2050012-2011-00447
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 16, 2011
    Report Date
    January 18, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN THE ESTABLISHED RANGES, BUT ON THE LOW SIDE OF THE RANGE. WHEN RECALIBRATION DID NOT BRING SODIUM (NA) RECOVERIES HIGHER, THE CUSTOMER TRIED A NEW BOTTLE OF ISE REFERENCE REAGENT AND RECALIBRATED. THIS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER WAS CONTACTED BY BECKMAN COULTER INC. (BCI) VIA ISE MARKET SURVEILLANCE CALL AND REPORTED ERRONEOUSLY LOW SODIUM (NA) RESULTS GENERATED BY UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER FOR TWO PATIENT SAMPLES. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIANS BECAUSE THE RESULTS DID NOT MATCH PATIENT HISTORY. THE LAB CHECKED A "CONTROL" SAMPLE AND ITS RESULT WAS ALSO LOW. THE SAMPLES WERE NOT REPEATED BUT THE PHYSICIAN HAD THE PATIENTS REDRAWN. SUBSEQUENT TESTING ON THE REDRAWN SAMPLES PRODUCED RESULTS APPROXIMATELY 8 MMOL/L HIGHER THAN THE ORIGINAL RESULTS. 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® CHEMISTRY ANALYZER CLINICAL CHEMSTRY ANALYZER JGS BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1