BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2012480 · Received March 10, 2011

    Report

    Report Number
    2122870-2011-00595
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 6, 2011
    Report Date
    February 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER LOADED A NEW PACK OF TBHCG AND PERFORMED A CALIBRATION, WHICH FAILED.THE CUSTOMER DETERMINED THE TBHCG REAGENT PACK WAS NOT LOADED INTO THE CORRECT SLOT IN THE REAGENT CAROUSEL AND REQUESTED HOTLINE'S ASSISTANCE TO CORRECTLY PLACE IT.HOTLINE INSTRUCTED THE CUSTOMER ON HOW TO PROPERLY REMOVE AND RELOAD REAGENT PACK.HOTLINE ALSO DISCUSSED WITH THE CUSTOMER WHY THE REAGENT PACK NEEDS TO BE DISCARDED DUE TO POSSIBLE ERRONEOUS RESULTS.SERVICE WAS NOT DISPATCHED FOR THIS EVENT, SINCE USE ERROR IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THE TOTAL BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) REAGENT PACK WAS MISLOADED IN THE INCORRECT SLOT OF THE REAGENT STORAGE CAROUSEL.THE EVENT WAS DISCOVERED DURING TROUBLESHOOTING. WHEN THIS OCCURS THE INSTRUMENT DOES NOT DETECT THE INCORRECT REAGENT PACK OR THE ABSENCE OF THE REAGENT PACK.NO PATIENTS WERE ANALYZED ON THE MISLOADED PACK DURING 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1