BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU640 CHEMISTRY ANALYZER

    MDR report key: 1811785 · Received August 23, 2010

    Report

    Report Number
    2050012-2010-00588
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 25, 2010
    Report Date
    August 23, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS PERFORMING QC ON THE INSTRUMENT AND RECEIVED CUVETTE WASH UNIT ERROR; HOWEVER THE CUSTOMER DISREGARDED THE ERROR MESSAGE. THE (B)(4) ONLINE HELP INSTRUCTS THE USER TO REMOVE OBSTRUCTION IF PRESENT AND CONTACT TECH SUPPORT; HOWEVER, THE CUSTOMER RESET THE INSTRUMENT WITH NO ACTION AND PROCEEDED TO RE-RUN QC. THE CUSTOMER IMMEDIATELY NOTICED THE FLAME AND SMOKE AT THE TOP REAR OF THE INSTRUMENT AND CONTACTED CALL CENTER. A BCI FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE FLAME/SMOKE AND CONCLUDED BASED ON HIS ASSESSMENT THAT THE FLAME APPEARED TO HAVE CAUSED BY A LEAK FROM TUBING LEADING TO DI/DETERGENT DISPENSE MANIFOLD, WHICH MAY HAVE SHORTED THE BOARD. FSE ASSESSMENT IS BASED ON THE LOCATION OF THE FLAME. ALTHOUGH LEAK IS A LIKELY CONTRIBUTOR TO THIS EVENT, A CLEAR ROOT CAUSE CAN NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO SMOKE BEING RELEASED FROM THE AU640 CHEMISTRY ANALYZER. PATIENT RESULT OR CUSTOMER WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU640 CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1