BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2222352 · Received August 25, 2011

    Report

    Report Number
    2122870-2011-03263
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 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
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND DISCOVERED THAT THE WASH BUFFER WAS LEAKING FROM THE RESERVOIR OUTLET FITTING. THE FSE REPLACED THE WASH BUFFER RESERVOIR AND VERIFIED THE SYSTEM PERFORMANCE TO PUBLISHED SPECIFICATIONS. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING A LEAK NEAR THE WASH BUFFER RESERVOIR OF THE ACCESS 2 IMMUNOASSAY SYSTEM. THERE WAS NO EXPOSURE TO BIO-HAZARDOUS FLUIDS. NO INJURY WAS REPORTED IN THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1