BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2172082 · Received June 15, 2011

    Report

    Report Number
    2122870-2011-01786
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    February 5, 2009
    Report Date
    February 9, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE ON 02/11/2009. THE FSE INSPECTED THE INSTRUMENT AND FOUND ONE ASPIRATE PROBE WAS NOT LOCKED INTO ITS PLACE PROPERLY, AND THE SUBSTRATE FITTING WAS LOOSE. ALSO, THE FSE ADJUSTED THE TRANSDUCER ULTRASONIC'S. THE FSE VERIFIED THAT THE INSTRUMENT IS PERFORMING TO SPECS. ALTHOUGH, SEVERAL HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC, (BCI) ON 02/09/2009 IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN) RESULTS IN THE RISK STRATIFICATION RANGE FOR UNSPECIFIED NUMBER OF PTS. THE RESULTS WERE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE INITIAL ERRONEOUSLY ELEVATED ACCUTNI RESULTS WERE REPORTED OUTSIDE THE LAB. THE SPECIFIC NUMBER OF RESULTS REPORTED OUT WAS NOT KNOWN. THE CUSTOMER RE-RAN THE SAMPLE AND IT WAS WITHIN THE REFERENCE RANGE. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PT 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 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ACCUTNI