BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2183592 · Received July 8, 2011

    Report

    Report Number
    2122870-2011-02072
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 21, 2008
    Report Date
    June 23, 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

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A BCI FIELD SERVICE ENGINEER (FSE) DID NOT EVALUATE THE DEVICE. QUALITY CONTROL (QC) DATA CHARTS WERE REVIEWED AND ALL LEVELS WERE WITHIN EXPECTED RANGE ON THE DATE OF EVENT. THE CUSTOMER INDICATED THAT A PRE-ANALYTICAL SAMPLE HANDLING ISSUE OCCURRED WITH THE SAMPLE. CUSTOMER ERROR IS THE ROOT CAUSE FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ELEVATED ACCUTNI (TROPONIN I) RESULTS GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE INITIAL ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER RE-CENTRIFUGED, ALIQUOTED AND RE-RAN THE SAMPLE ON A DIFFERENT INSTRUMENT AND THE RESULT WAS WITHIN NORMAL REFERENCE RANGE. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PATIENT EVENT.

    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 52 YR ACCESS ACCUTNI