BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2252960 · Received September 9, 2011

    Report

    Report Number
    2122870-2011-03698
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    January 12, 2009
    Report Date
    January 13, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE ON (B)(6) 2009 TO INVESTIGATE THE EVENT. THE CUSTOMER STATED TO THE FSE THAT THEY ARE NO LONGER RUNNING ACCUTNI ON THIS INSTRUMENT. THE FSE DID NOT PERFORM HARDWARE VERIFICATION AS THE INSTRUMENT IS BEING REPLACED. THEREFORE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. THIS IS 1 OF 5 SEPARATE MDR REPORTS RELATED TO 5 PATIENT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS: MDR 2122870-2011-03699, 03700, 03701, 03702 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 THROUGH (B)(4), 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN I) RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR FIVE PATIENT. THE PATIENT SAMPLES WERE SENT TO ANOTHER REFERENCE LABAND RETESTED ON A DIFFERENT INSTRUMENT. THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PATIENT TREATMENT. THERE IS NO INDICATION OF AN ADVERSE EVENT OR INDICATION OF ANY MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM JJE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI