BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2193439 · Received May 11, 2011

    Report

    Report Number
    2122870-2011-01320
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    September 23, 2008
    Report Date
    September 29, 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

    FIELD SVC ENGINEER (FSE) WAS ONSITE ON (B)(4) 2008 AND FOUND GEL ON THE SAMPLE PROBE. THE SAMPLE PROBE WAS REPLACED AND ALIGNMENTS VERIFIED. THE FSE RETURNED ON (B)(4) 2008 AND (B)(4) 2008 AND RAN SYS CHECKS, CARRYOVER ASSESSMENT, AND SUBSTRATE DECONTAMINATION TO VERIFY REPAIRS. NO ISSUES WERE NOTED. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED FROM THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN 01/01/2008 AND 10/23/2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING ONE NON-REPRODUCIBLE RESULT ON ONE PT FOR TROPONIN ASSAY. THE CUSTOMER RE-RAN THE SAMPLES AND THEY WERE WITHIN THE RANGE SPEC. THE INITIAL, ELEVATED ACCUTNI (TROPONIN) RESULT WAS REPORTED OUTSIDE THE LAB. IT IS UNK IF THERE ARE REPORTS OF ANY ADVERSE PT CONSEQUENCE OR CHANGE TO THE PT'S TREATMENT. THERE ARE NO INDICATIONS OF 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 60 YR ACCESS ACCUTNI