BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2223225 · Received August 12, 2011

    Report

    Report Number
    2122870-2011-02872
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    August 10, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    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 DISPATCHED TO THE SITE TO INVESTIGATE THE EVENT. THE FSE INSPECTED THE INSTRUMENT AND FOUND GEL ON THE SAMPLE PROBE. THE FSE PRIMED THE SYSTEM AND PERFORMED THE CARRYOVER TEST, WHICH PASSED. THE FSE REPLACED THE SAMPLE PROBE AND VERIFIED ALL ALIGNMENTS. HARDWARE VERIFICATION TESTING ALL PASSED WITHIN SPECIFICATIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. 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 ERRONEOUSLY ELEVATED ACCU TNI (TROPONIN I) RESULTS GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE INITIAL ERRONEOUSLY ELEVATED RESULT WAS REPORTED OUTSIDE THE LAB. THE CUSTOMER ALIQUOTED AND RE-CENTRIFUGED THE SAMPLE PRIOR TO RE-RUNNING IT. THE RESULTS OF THE RE-RUN WERE WITHIN THE NORMAL REFERENCE RANGE. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCU TNI