BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1994073 · Received February 16, 2011

    Report

    Report Number
    2122870-2011-00389
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DISCOVERED WHILE TROUBLESHOOTING WITH HOTLINE, NO INHIBIN A REAGENT PACK WAS PRESENT IN THE DESIGNATED SLOT IN THE REAGENT STORAGE CAROUSEL. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE ROOT CAUSE WAS DETERMINED DURING TROUBLESHOOTING WITH HOTLINE. USE ERROR IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) REGARDING OBTAINING IND/NO VALUE FLAGS IN DUPLICATE FOR INHIBIN A ON THREE LEVELS OF QC ON ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER OBTAINED THE SAME IND/NO VALUE UPON REPEAT. THE CUSTOMER IS COMFORTABLE WITH ALL PATIENTS' RESULTS REPORTED AND IS NOT REPORTING ANY ERRONEOUS RESULTS. 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. ACCESS® 2 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1