BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2073498 · Received May 2, 2011

    Report

    Report Number
    2122870-2011-01036
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 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
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE INSPECTED THE INSTRUMENT AND FOUND VACUUM PUMP TO BE AT FAULT. THE FSE REPLACED VACUUM PUMP AND VERIFIED SYSTEM PERFORMANCE TO PUBLISHED SPECIFICATIONS. HARDWARE HAS BEEN DETERMINED TO BE THE ROOT CAUSE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING "VACUUM UNDER LIMITS'" ERRORS AND THEY NOTED A LEAK OUT OF THE FRONT CENTER OF THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER DID NOT REPORT ANY EXPOSURE TO HAZARDOUS LIQUIDS OR ANY INJURIES RELATED TO 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

    Patients

    Seq Age Sex Outcome Treatment
    1