BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2082423 · Received May 9, 2011

    Report

    Report Number
    2122870-2011-01338
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI FIELD SERVICE ENGINEER (FSE) WAS ONSITE ON (B)(4) 2011. THE FSE FOUND THAT A CLOT WAS CAUSING THE LEAK IN THE WASH TOWER. THE FSE CLEANED THE CLOT OUT, CHANGED WASH TOWER VALVE AND FLUSHED THE VACUUM PUMP. THE FSE VERIFIED SYSTEM PERFORMANCE TO THE PUBLISHED SPECIFICATION. ALTHOUGH PRE-ANALYTICAL SAMPLE HANDLING IS A CONTRIBUTING FACTOR, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) CONCERNING A LIQUID LEAK FROM THE WASH TOWER OF ACCESS 2 IMMUNOASSAY SYSTEM THAT CAUSED THE INSTRUMENT TO SPARK. THERE WAS NO REPORT OF INJURY OR EXPOSURE TO HAZARDOUS FLUIDS.

    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