BEUDAMED
    FDA Adverse Event Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1880706 · Received October 25, 2010

    Report

    Report Number
    2122870-2010-00644
    Date Received
    October 25, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ANALYZED WERE API SURVEY SAMPLES AND NO PATIENT SAMPLES WERE ANALYZED DURING THIS EVENT. DURING TROUBLESHOOTING THE EVENT WITH ACCESS HOTLINE, THE CUSTOMER DISCOVERED THAT THE REAGENT PACKS WERE MIS-LOADED AND NOT INSERTED IN THE CORRECT SLOTS ON THE REAGENT STORAGE CAROUSEL. THE CUSTOMER REMOVED AND DISCARDED THE MIS-LOADED REAGENT PACKS. CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER IN PROPERLY LOADING REAGENT PACKS ON THE REAGENT CAROUSEL. SERVICE WAS NOT DISPATCHED USER ERROR IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO NO READING ON TWO HYBRITECH PSA (HYB-PSA) RESULTS FOR TWO SURVEY SAMPLES GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SURVEY SAMPLES WERE REPEATED AFTER RELOADING A HYB-PSA REAGENT PACK AND OBTAINED HIGHER RESULTS. THE PATIENT TREATMENT WAS NOT IMPACTED BY 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