BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2142179 · Received May 26, 2011

    Report

    Report Number
    2122870-2011-01140
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    August 17, 2009
    Report Date
    August 18, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND FOUND THAT THE CUSTOMER HAD IMPROPERLY ROUTED THE ASPIRATE PROBE TUBING. THE FSE REPLACED ASPIRATE PROBES AND PERI-PUMP TUBING. THE FSE EXPLAINED TO THE CUSTOMER THE IMPORTANCE OF PROPERLY ROUTING THE ASPIRATE PROBE TUBING AND THE CORRECT MANNER IN WHICH TO ROUTE THE TUBING. THE EVENT WAS CONSIDERED ATTRIBUTABLE TO USER ERROR. 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 DXI 800 ACCESS IMMUNOASSAY ANALYZER INSTRUMENT. A REPEAT OF THE PT SAMPLES RUN GAVE RESULTS WITHIN THE EXPECTED RANGE. THE CUSTOMER RE-RAN THE PT SAMPLE ON ANOTHER DXI INSTRUMENT AND THE ACCU-TNI RESULT WAS IN THE EXPECTED RANGE. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND WHILE THERE IS NO REPORT OF ANY ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNKNOWN WHETHER THERE WAS ANY CHANGE TO PT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI