BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2142180 · Received May 26, 2011

    Report

    Report Number
    2122870-2011-01145
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    September 27, 2009
    Report Date
    September 27, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) PERFORMED A SYSTEM CHECK ON THE INSTRUMENT AND FOUND THAT THE INSTRUMENT MET SPECIFICATIONS. ADDITIONALLY, IT WAS FOUND THAT THREE LEVELS OF QUALITY CONTROL (QC) CHECKS WERE PERFORMED THE DAY OF THE EVENT AND THEY ALL RECOVERED WITHIN THE CUSTOMER'S ESTABLISHED RANGES. NO CLEAR ROOT CAUSE FOR THIS EVENT COULD BE IDENTIFIED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 TO (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BCI) THAT AN ERRONEOUSLY HIGH TROPONIN (ACCU-TNI) RESULT WAS OBTAINED ON THE UNICEL DXC 600I INSTRUMENT. THE CUSTOMER RE-RAN THE PT SAMPLE AND THE ACCU-TNI RESULT WAS WITHIN THE EXPECTED RANGE. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE IS NO REPORT OF ANY ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT AND THERE WAS NO CHANGE TO PT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI