BEUDAMED
    FDA Adverse Event Other Summary report: N

    BECKMAN COULTER ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 383279 · Received March 13, 2002

    Report

    Report Number
    2122870-2002-00003
    Event Type
    Other
    Date Received
    March 13, 2002
    Date of Event
    February 10, 2002
    Report Date
    March 8, 2002
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DDR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT A MYOGLOBIN REAGENT PACK, WITH 10 TESTS REMAINING, WAS LOADED ON AN ACCESS INSTRUMENT AND 10 TESTS WERE RUN. THE FIRST TWO RESULTS WERE ACCEPTABLE AND THE REMAINING 8 TEST RESULTS WERE ALL 0.0 WITH NO SYSTEM FLAGS. TWO OF THE 0.0 RESULTS WERE REPORTED. REPEAT TESTING OF THE 0.0 SAMPLES PRODUCED NORMAL RESULTS. NO TREATMENT WAS INITIATED OR WITHELD BASED ON THESE RESULTS. INVESTIGATION DETERMINED THAT THE MYOGLOBIN PACK WAS USED PREVIOUSLY ON A DIFFERENT ACCESS SYSTEM AND WAS MOVED TO THE ACCESS SYSTEM IN QUESTION WHERE THE 0.0 RESULTS WERE PRODUCED. PRODUCT LABELING CLEARLY STATES THAT ACCESS REAGENT PACKS CANNOT BE REMOVED AND USED ON A DIFFERENT SYSTEM. THE SECOND INSTRUMENT ASSUMES A FULL REAGENT CARTRIDGE HAS BEEN LOADED AND WHEN THE CARTRIDGE HAS ALREADY BEEN USED ON A DIFFERENT INSTRUMENT, THE REAGENT VOLUME WILL BE LESS THAT ASSUMED. THIS IS A USER ERROR, IN THAT, FAILURE TO FOLLOW INSTRUCTIONS RESULTED IN THE INCORRECT RESULT. A POTENTIAL HEALTH RISK TO THE PATIENT DOES EXIST WHEN A FALSE 0.0 MYOGLOBIN RESULT IS REPORTED. A 0.0 MYOGLOBIN RESULT COULD BE USED BY A PHYSICIAN IN THE COURSE OF PATIENT CARE, AND HAS THE POTENTIAL TO AFFECT THE DIAGNOSIS OR MODIFY A COURSE OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER ACCESS IMMUNOASSAY SYSTEM CLINICAL IMMUNOASSAY ANALYZER DDR BECKMAN COULTER, INC. ACCESS INSTRUMENT MYOGLOBIN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other