BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2213725 · Received August 16, 2011

    Report

    Report Number
    2122870-2011-02945
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE (B)(6) 2011. FSE DISCOVERED 2 TRANSISTORS ON THE STEPPER MOTOR DRIVER BOARD WERE BURNED. FSE REPLACED THE STEPPER MOTOR DRIVER BOARD AND INSPECTED THE MAIN PIPETTOR MOTORS AND CONNECTORS AND FOUND NO SHORTS. FSE VERIFIED INSTRUMENT OPERATION, PRIMED THE SYSTEM, PERFORMED THE DAILY CLEAN PROCEDURE AND ASSAY QC AND NO ISSUES WERE NOTED. ALL REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND ALL RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. HARDWARE IS THE ROOT CAUSE OF THIS EVENT. THE BEC INTERNAL IDENTIFIER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING SMOKE WAS COMING FROM THE RIGHT HAND SIDE OF THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER UNPLUGGED THE POWER CORD OF THE SYSTEM AND WAITED FOR SERVICE TO ARRIVE. NO FIRE WAS OBSERVED. THERE WAS NO INJURY REPORTED AND THE FIRE DEPARTMENT WAS NOT CALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1