BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU681-02E CHEMISTRY ANALYZER

    MDR report key: 2080811 · Received May 6, 2011

    Report

    Report Number
    2050012-2011-01516
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATOR LOADED A FRESH CREATININE REAGENT CARTRIDGE WITHOUT CALIBRATING AND RUNNING CONTROLS AS REQUIRED IN THE INSTRUCTIONS FOR USE. LABORATORY PRACTICE CONTRIBUTED TO ERROR BY FIXING REAGENT ON BOARD INSTRUMENT TO DISABLE ON BOARD LIMITS TO REAGENT USE AND THE AUTOMATIC REQUIREMENT FOR CALIBRATION OF NEW BOTTLES OF CREATININE REAGENT. USER ERROR IS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO OBTAINING AN ERRONEOUSLY HIGH SERUM CREATININE (CRE) RESULT AND AN ERRONEOUSLY LOW CALCULATED ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) RESULT THAT WERE GENERATED BY THE AU681-02E CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE PATIENT SAMPLE WAS RETESTED AFTER PROPER CALIBRATION AND AMENDED REPORTS WERE RELEASED WITHIN 20 HOURS. ORDERING DOCTORS WERE CONTACTED AND REVISED RESULTS WERE TRANSMITTED. IT IS UNKNOWN IF PATIENT TREATMENT WAS AFFECTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU681-02E CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1