BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 3974321 · Received August 1, 2014

    Report

    Report Number
    2122870-2014-00556
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE PRINTED CIRCUIT BOARDS (PCBS) AND VERIFIED INSTRUMENT OPERATION BY COMPLETING A SUCCESSFUL SYSTEM CHECK AND QUALITY CONTROL (QC). THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE BURNT STEPPER MOTOR DRIVER PCB. A DEFINITIVE ROOT CAUSE IS UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BURNING ODOR AND NOTICED WHITE SMOKE EMITTED FROM THE REAGENT CAROUSEL INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER IMMEDIATELY TURNED OFF THE INSTRUMENT AND NOTED THE SMOKE STOPPED. THE CUSTOMER STATED THERE WERE NO SPARKS AND THE FIRE DEPARTMENT WAS NOT REQUESTED. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450218 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1