BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 2001989 · Received February 27, 2011

    Report

    Report Number
    2050012-2011-00547
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, THE CUSTOMER PERFORMED A MONTHLY MAINTENANCE ON THE GLUM, CALIBRATED AND RAN BIO RAD MULTIQUAL QC. THE L3 QC WAS IN RANGE ON THE HIGH SIDE OF THE MEAN (EXPECTED MEAN IS 363.1 MG/DL AND RANGE OF 347.1 - 379.1 MG/DL). ON (B)(6) 2011, THE CUSTOMER NOTICED THE QC ON THE BIO RAD MULTIQUAL L3 CONTROL READ OUT HI AROUND 384 MG/DL. THE CUSTOMER RECALIBRATED THE TEST AND L3 QC WAS IN RANGE. SINCE THE L3 QC HAD READ OUT HI EARLIER, THE CUSTOMER DECIDED TO RERUN SOME SAMPLES THAT WERE RUN EARLIER AND NOTICED THAT THE RERUN RESULTS DID NOT MATCH. SERVICE REPLACED THE GLUCOSE ACCUSENSE ELECTRODE. QA SPOKE WITH CUSTOMER TO CONFIRM THEY ARE INVERTING A FRESH BOTTLE OF REAGENT 5 TIMES AFTER SITTING AT ROOM TEMPERATURE FOR 8 HOURS PRIOR TO LOADING ON THE INSTRUMENT. ROOT CAUSE APPEARS TO BE THE ELECTRODE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) IN REGARDS ERRONEOUS GLUCOSE MODULAR (GLUM) RESULTS ON APPROXIMATELY 349 PATIENTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED, AMENDED, AND REPORTED. THE CUSTOMER CONFIRMED THAT NO PATIENT TREATMENT WAS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER. CLINICAL CHEMISTRY ANALYZER, CGA BECKMAN COULTER INC. DXC800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1