BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2240201 · Received September 9, 2011

    Report

    Report Number
    2122870-2011-03410
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 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
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE FOUND THAT ONE OF THE DEVICE DRIVER PRINTED CIRCUIT BOARDS HAD FAILED. THE FSE REPLACED THE BOARD AND EXERCISED THE PIPETTOR MULTIPLE TIMES TO ENSURE PROPER OPERATION. THE FSE PERFORMED A ROUTINE SYSTEM CHECK AND ASSAY QC. NO ISSUES WERE NOTED. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT A BURNING SMELL EMITTING FROM THE ACCESS 2 IMMUNOASSAY ANALYZER. THERE WERE NO REPORTS OF FLAMES, FIRE, OR INJURY. THERE WAS NO INDICATION THAT THE FIRE DEPARTMENT WAS DISPATCHED. THE CUSTOMER STATED THAT NO SAMPLES WERE PROCESSED AT THE TIME OF THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1