BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1200385 · Received October 15, 2008

    Report

    Report Number
    2122870-2008-00322
    Event Type
    Other
    Date Received
    October 15, 2008
    Date of Event
    July 24, 2008
    Report Date
    October 15, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION, HANDLING AND STORAGE DETAILS WERE NOT SUPPLIED. QC AND SYSTEM CHECK DETAILS WERE NOT SUPPLIED, HOWEVER, PER CUSTOMER UPDATE IN 2008, QC PERFORMANCE HAS REMAINED ACCEPTABLE AND CUSTOMER HAS NOT HAD ISSUES WITH ANY OTHER ASSAY. A FIELD SERVICE ENGINEER (FSE) PERFORMED A PREVENTIVE MAINTENANCE (PM) ON THE MONTH BEFORE, AND RETURNED ON-SITE FIVE DAYS LATER: FSE REPLACED THE WASH PUMP DUE TO DIFFICULTIES CALIBRATING THE BACKLASH FOLLOWING THE PM. FSE PERFORMED SYSTEM CHECK AND A PRECISION RUN. ALL TESTS MET SPECIFICATIONS. FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUS ACCUTNI RESULTS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR SEVERAL PATIENTS. SAMPLES OBTAINED FROM 11 PATIENTS WERE TESTED FOR ACCUTNI AND THE RESULTS OBTAINED WERE IN THE RANGE OF 0.51 - 1.13NG/ML. THESE SAMPLES WHEN RE-TESTED GAVE RESULTS IN THE RANGE 0.00 - 0.25NG/ML. UPON RE-TESTING FOR A SECOND TIME, THE RESULTS WERE IN THE RANGE OF 0.00-0.23NG/ML. FOUR OF THE PATIENT SAMPLES WERE RE-TESTED FOR THE THIRD TIME AND GAVE RESULTS IN THE RANGE 0.01-0.12NG/ML. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. NO REPORT OF CHANGE PATIENT TREATMENT HAS BEEN RECEIVED TO DATE REGARDING 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA