BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2160262 · Received June 2, 2011

    Report

    Report Number
    2122870-2011-01594
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    October 24, 2008
    Report Date
    October 26, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    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 ON (B)(4) 2008. THE FSE ADJUSTED THE ASPIRATE PROBE Z ALIGNMENT. ALSO, THE FSE PERFORMED SYSTEM CHECK AND HIGH SENSITIVITY (HS) CHECK WITH PASSING RESULTS. THE FSE RAN THE QUALITY CONTROLS (QC) WITH SAMPLES AND INDICATED THE INSTRUMENT PERFORMANCE IS ACCEPTABLE. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC, (BCI) ON (B)(6) 2008 IN REGARDS TO A NON-REPRODUCIBLE ELEVATED ACCUTNI (TROPONIN) RESULT IN THE RISK STRATIFICATION RANGE FOR ONE PATIENT. THE RESULTS WERE GENERATED ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE INITIAL ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER RE-RAN THE SAMPLE AND IT WAS WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER INDICATED THAT PRIOR PATIENTS ACCUTNI RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE CORRECTED RESULT WAS REPORTED. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCE OR CHANGE TO THE PATIENT'S TREATMENT. THERE ARE NO INDICATIONS OF ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PATIENT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI