BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1982590 · Received February 9, 2011

    Report

    Report Number
    2122870-2011-00344
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT A SERIES OF TEMPERATURE STATUS MONITOR ERROR MESSAGES WERE POSTED TO THE EVENT LOG JUST PRIOR TO THE BURNING SMELL. SERVICE WAS DISPATCHED ON 01/11/2011 FOR THIS EVENT. THE BCI FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT A CHASSIS/COVER SCREW HAD FALLEN ON THE OBSTRUCTION DETECTION PCB BOARD AND SHORTED IT OUT. THE FSE REPLACED THE BOARD AND ASSOCIATED RIBBON CABLE. THE FSE CALIBRATED THE OBSTRUCTION PRESSURE SENSOR AND PERFORMED A ROUTINE SYSTEM CHECK AND QC. ALL RESULTS WERE WITHIN THE SPECIFICATIONS. HARDWARE ISSUE WAS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO A BURNING SMELL COMING FROM ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER POWERED DOWN THE INSTRUMENT AND REMOVED ALL REAGENTS FOR OFF-BOARD STORAGE. THERE WAS NO FLAME OR FIRE, AND THE FIRE DEPARTMENT WAS NOT DISPATCHED. THERE WAS NO REPORT OF INJURY TO THE USER, AND THE CUSTOMER DID NOT SEEK OR NEED MEDICAL ATTENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1