BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2150045 · Received July 5, 2011

    Report

    Report Number
    2122870-2011-02136
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    Z-0607-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT FOLLOW THE OUTLINED PROCEDURE FOR LOADING A NEW REAGENT PACK ON THE SYSTEM. CUSTOMER'S QC WAS WITHIN PUBLISHED SPECIFICATIONS. THROUGH ROUTINE TROUBLESHOOTING WITH CUSTOMER, BEC CUSTOMER TECHNICAL SUPPORT (CTS) DISCOVERED THAT AN EXTRA PACK WAS LOADED ON THE INSTRUMENT THAT WAS NOT IN INVENTORY. PER CTS INSTRUCTIONS, CUSTOMER REMOVED REAGENT PACK AND DISCARDED IT. USER ERROR IS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) A REAGENT PACK MIS-LOAD ON THE ACCESS 2 IMMUNOASSAY ANALYZER. NO ERRONEOUS RESULTS WERE REPORTED. THERE ARE NO REPORTS OF PATIENT INJURY OR UNNECESSARY MEDICAL TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER, INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1