BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2190019 · Received August 4, 2011

    Report

    Report Number
    2122870-2011-02671
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLE WAS LITHIUM HEPARIN PLASMA. THE SAMPLE WAS CENTRIFUGED AT 4800 RPM FOR 5 MINUTES AT ROOM TEMPERATURE. THE SAMPLE WAS AN ASPIRATE FROM THE PRIMARY COLLECTION TUBE FOR ANALYSIS. THE SAMPLE WAS FILLED TO THE RECOMMENDED FILL LINE AND APPEARED CLEAR. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE EVENT. A SYSTEM CHECK PERFORMED ON (B)(6) 2011 FAILED THE UNWASHED %CV. THE UNWASHED PORTION WAS REPEATED AND MET SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A CLEAR ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING A TROPONIN (ACCUTNI) RESULT IN THE RISK STRATIFICATION RANGE FOR ONE (1) PATIENT, GENERATED BY A UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM, USED IN CONJUNCTION WITH ACCESS ACCUTNI REAGENT (LOT 110863) AND ACCESS ACCUTNI CALIBRATOR (LOT 018753). THIS RESULT WAS REPORTED OUT OF THE LAB. ACCORDING TO LAB PROTOCOL FOR CHECKING LOW POSITIVES, THE SAMPLE WAS REANALYZED ON THE SAME INSTRUMENT, WHICH GENERATED A RESULT WITHIN THE NORMAL REFERENCE RANGE. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 600 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE MMI BECKMAN COULTER, INC. DXI 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1