BEUDAMED
    FDA Adverse Event Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1871787 · Received October 15, 2010

    Report

    Report Number
    2122870-2010-00620
    Date Received
    October 15, 2010
    Date of Event
    September 18, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO TWO MISLOADED ACCUTNI REAGENT PACKS WERE DISCOVERED WHILE TROUBLESHOOTING REAGENT CAROUSEL MOTION ERRORS WITH HOTLINE ON THE ACCESS 2 IMMUNOASSAY ANALYZER. TESTING WAS NOT BEING PERFORMED ON THE INSTRUMENT WHEN THE PACKS WERE LOADED TO THE EVENT DISCOVERY DATE. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH 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. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1