BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2171199 · Received July 1, 2011

    Report

    Report Number
    2122870-2011-02084
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    July 24, 2008
    Report Date
    August 1, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS ON-SITE AND INVESTIGATED THE EVENT. THE FSE INSPECTED THE INSTRUMENT AND FOUND GEL FROM THE SAMPLE TUBES ON THE MAIN PIPETTOR WHICH IS THE ROOT CAUSE FOR THIS EVENT. THIS IS ONE OF TWO SEPARATE MDR REPORTS RELATED TO TWO PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBER: MDR 2122870-2011-02085 FOR ALL RELATED EVENTS. 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 I) RESULTS GENERATED ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TWO PTS. THE CUSTOMER INDICATED THAT THE SAMPLE WAS ALIQUOTED, RE-CENTRIFUGED, RE-RUN AND THE RESULTS WERE LOWER. THE INITIAL ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LAB. 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 DXI 800 ACCESS IMMUNOASSAY SYSTEM MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR ACCESS ACCUTNI