BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2242296 · Received September 10, 2011

    Report

    Report Number
    2122870-2011-03393
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, THE WASH BUFFER WAS SPILLED DUE TO A LEAK OF THE WASH BUFFER RESERVOIR FILTER SCREEN FITTING. SERVICE WAS NOT DISPATCHED. HOTLINE SENT THE CUSTOMER A NEW WASH BUFFER RESERVOIR WITH FITTING. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT. BEC INTERNAL IDENTIFICATION (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT THE FLUIDICS TRAY WAS LEAKING WASH BUFFER ONTO THE COUNTER BY THE ACCESS 2. 2. THE USER WAS WEARING PPE. NO REPORT OF INJURY OR USER EXPOSURE TO THE LIQUID WASTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER INC. ACCESS2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1