BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2110560 · Received June 1, 2011

    Report

    Report Number
    2122870-2011-01641
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THEY BELIEVE THE TRAY WAS CRACKED WHILE BEING MOVED IN THE LABORATORY. THE CUSTOMER WAS SENT A REPLACEMENT TRAY. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. USE ERROR WAS THE ROOT CAUSE FOR THIS EVENT. THE CUSTOMER WAS SENT REPLACEMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) CONCERNING A LIQUID LEAK FROM THE INSTRUMENT FLUID TRAY ON ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER STATED THAT ALL PERSONNEL WERE WEARING PROPER PPE. THERE WERE NO REPORTS OF INJURIES OR EXPOSURE TO HAZARDOUS LIQUIDS.

    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