BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2063559 · Received April 19, 2011

    Report

    Report Number
    2122870-2011-01022
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 20, 2011
    Report Date
    March 20, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2011. THE FSE DISCOVERED THE INSTRUMENT WAS LEAKING BUFFER FROM THE WASH BUFFER RESERVOIR, AND INSTALLED A NEW WASH BUFFER RESERVOIR. THE FSE VERIFIED HARDWARE BY PERFORMING A SYSTEM CHECK. THE RESULTS WERE WITHIN THE INSTRUMENT SPECIFICATIONS. HARDWARE WAS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO A FLUID LEAK COMING FROM THE BOTTOM OF ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER CLEANED THE LEAK AND THERE WAS NO EXPOSURE TO THE LIQUID. THERE WAS NO REPORT OF INJURY.

    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