BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2324080 · Received November 3, 2011

    Report

    Report Number
    2122870-2011-04938
    Event Type
    Malfunction
    Date Received
    November 3, 2011
    Date of Event
    October 4, 2011
    Report Date
    October 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE (B)(4) 2011, FOR THIS EVENT AND NOTED THAT THE SMELL WAS COMING FROM THE LEFT CARD CAGE OF THE ANALYZER. UPON INSPECTION OF THE PCB BOARDS, FSE DISCOVERED THAT THE FAN ON THE CPU BOARD HAD SEIZED AND THERE WAS MELTED PLASTIC STUCK TO THE FAN BLADES AND THE MELTED PLASTIC HAD DRIPPED ONTO THE HARD DRIVE RIBBON CABLE AS WELL. FSE REPLACED THE CPU PCB BOARD AND THE HARD DRIVE RIBBON CABLE. FSE THEN CALIBRATED THE PRESSURE SENSORS AND PERFORMED A ROUTINE SYSTEM CHECK WHICH PASSED WITHIN THE INSTRUMENT SPECIFICATIONS. HARDWARE IS THE ROOT CAUSE OF THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AFTER RECEIVING COMMUNICATION ERRORS FROM THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. BEC CTS (CUSTOMER TECHNICAL SUPPORT) PERFORMED TROUBLESHOOTING AND HAD THE CUSTOMER REBOOT THE PC AND THE ANALYZER. THE CUSTOMER THEN NOTICED SMELL OF MELTING PLASTIC FROM THE INSTRUMENT 30 MINUTES LATER. UPON OPENING THE INSTRUMENT TO INSPECT, CUSTOMER NOTED THAT THE SMELL WAS STRONGER. THERE WAS NO FLAME, ARCH, OR SMOKE. CTS HAD CUSTOMER POWER DOWN AND DISCONNECT POWER SOURCE TO THE ANALYZER AND WAIT FOR SERVICE. NO INJURY WAS REPORTED AND MEDICAL ATTENTION WAS NOT SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1