BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2110508 · Received June 1, 2011

    Report

    Report Number
    2122870-2011-01624
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 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

    SERVICE WAS DISPATCHED ON (B)(4) 2011, BUT THE FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPRODUCE ANY VACUUM ISSUES UNDER LIMITS ERRORS. THE FSE NOTED THAT THE FLUID APPEARED TO HAVE COME FROM THE REAGENT CAROUSEL. THE FSE REPLACED THE THERMISTOR WHICH CONTROLS THE TEMPERATURE INSIDE THE REAGENT CAROUSEL. WHEN THE TEMPERATURE INSIDE THE REAGENT CAROUSEL IS NOT MAINTAINED WITHIN A RANGE, THE REAGENT CAROUSEL WILL BEGIN TO LEAK DUE TO MELTING ICE. IT IS UNKNOWN IF THE WATER FROM THE ICE CONTAINED OTHER MATERIALS WHICH MAY HAVE POTENTIAL FOR BIOHAZARD EXPOSURE. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) CONCERNING A LIQUID LEAK FROM ACCESS 2 IMMUNOASSAY SYSTEM AS WELL AS VACUUM UNDER LIMITS ERRORS. THE CUSTOMER CONFIRMED THAT PROPER PPE WERE USED WHEN CLEANING UP THE LEAK AND THERE WERE NO ADVERSE EXPOSURE EVENTS. THE CUSTOMER STATED THAT MSDS WAS NOT REVIEWED, BUT THE FACILITY DOES HAVE A RISK MANAGEMENT PLAN IN PLACE. THERE WAS NO REPORT OF INJURY.

    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