BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2083675 · Received May 10, 2011

    Report

    Report Number
    2122870-2011-01360
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVENT LOG MESSAGE WAS NOTED BY THE CUSTOMER. SERVICE WAS DISPATCHED ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) FOUND A LOOSE WASTE DRAIN LINE CONNECTION LOCATED NEXT TO THE PERI-PUMP. THE FSE RECONNECTED THE TUBING AND VERIFIED SYSTEM PERFORMANCE TO PUBLISHED SPECIFICATIONS. HARDWARE WAS 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. THERE WAS NO 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