BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2073184 · Received April 29, 2011

    Report

    Report Number
    2122870-2011-01035
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011. THE FSE FOUND A FAULTY VACUUM PUMP WHICH WAS REPLACED. THE FSE VERIFIED SYSTEM PERFORMANCE TO PUBLISHED SPECIFICATIONS. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING "VACUUM UNDER LIMITS" ERRORS AND A LEAK FROM THE FRONT OF ACCESS 2 IMMUNOASSAY SYSTEM. THERE WAS NO REPORT OF INJURY TO LAB PERSONNEL.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1