BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2180909 · Received July 1, 2011

    Report

    Report Number
    2122870-2011-02070
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    July 7, 2008
    Report Date
    July 8, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE ON (B)(6) 2008 TO INVESTIGATE THE EVENT. THE FSE REPLACED THE TRANSDUCER AND THE CENTER MIXER BEARING. ALSO, THE FSE FOUND A SPILL ON THE WASH WHEEL AND NOTED THE ANALYZER HAD BEEN ON A COUNTER WITHOUT SUPPORT ON THE FRONT LEFT CORNER. THE FSE CLEANED THE WASH WHEEL AND THE ANALYTICAL MODULE WASH AREA. FURTHER INVESTIGATION ON THE INSTRUMENT REVEALED THAT THE RVS ARE HITTING THE INCUBATOR BELT WHEN LEAVING THE SHUTTLE. THE FSE ADJUSTED THE INCUBATOR BELT HOME POSITION AND PERFORMED CALIBRATION AND ALIGNMENTS. THE FSE PERFORMED HIGH SENSITIVITY (HS) SYSTEM CHECK, ACCUTNI CALIBRATION, AND QUALITY CONTROLS (QC) AND ALL TESTING MET SPECIFICATIONS. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6) 2008 THROUGH (B)(6) 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) RESULT GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. THE INITIAL ERRONEOUSLY ELEVATED RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT SAMPLE WAS RETESTED AND THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. 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 MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI