BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2152330 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-02030
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 22, 2008
    Report Date
    May 23, 2008
    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

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) DID NOT EVALUATE THE INSTRUMENT. THE CUSTOMER INDICATED THAT THE ORIGINAL ERRONEOUS RESULT WAS RUN ON THE WRONG PT SAMPLE. CUSTOMER ERROR DUE TO SAMPLE MIX-UP IS THE ROOT CAUSE OF THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 THROUGH (B)(4), 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC, (BCI) IN REGARDS TO ERRONEOUS ACCUTNI (TROPONIN) RESULT GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER RE-RAN THE SAMPLE AND IT WAS WITHIN THE NORMAL 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 72 YR ACCESS ACCUTNI