BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 3924455 · Received July 9, 2014

    Report

    Report Number
    2122870-2014-00503
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE STEPPER MOTOR DRIVER PCB (PRINTED CIRCUIT BOARD). A DEFINITIVE CAUSE OF THE BURNT PCB IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    DURING SYSTEM DIAGNOSTICS FOR PIPETTER MOTION ERRORS, THE FIELD SERVICE ENGINEER (FSE) DISCOVERED A BURNT STEPPER MOTOR DRIVER PCB (PRINTED CIRCUIT BOARD) ON THE ACCESS 2 SYSTEM. THE FSE REPLACED THE PCB AND COMPLETED SYSTEM CHECK AND NOTED THE UNWASHED PORTION WAS OUT OF SPECIFICATION. THE FSE THEN REPLACED THE PRECISION VALVE ROTOR, STATOR AND SPRING IN THE PRECISION PUMP, AND COMPLETED ADJUSTMENT TO THE PRECISION VALVE - SYSTEM CHECK THEN PASSED THE UNWASHED PORTION. THE CUSTOMER INDICATED THERE WAS NO SMOKE OR FIRE, AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401979 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1