BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2159420 · Received July 12, 2011

    Report

    Report Number
    2122870-2011-02269
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 12, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED GETTING VACUUM OVER LIMITS ERRORS AND DISCOVERED A SMALL PUDDLE (~4" DIAMETER) UNDER THE RIGHT SIDE OF THE INSTRUMENT ON THE COUNTER. SERVICE WAS ONSITE ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) FOUND THE WASH TOWER WAS OVERFLOWING. THE FSE REPLACED THE VACUUM VALVE AND VERIFIED SYSTEM PERFORMANCE TO PUBLISHED SPECIFICATIONS. HARDWARE HAS BEEN DETERMINED TO BE THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) A LIQUID LEAK FROM ACCESS 2 IMMUNOASSAY ANALYZER. THERE WERE NO REPORTS OF INJURIES OR EXPOSURE TO HAZARDOUS LIQUIDS TO USERS OR LAB VISITORS. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1