BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2172083 · Received June 15, 2011

    Report

    Report Number
    2122870-2011-01793
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    February 15, 2009
    Report Date
    February 15, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE ON (B)(4) 2009. THE FSE REPLACED THE SAMPLE PROBE AND REMOVED GEL FROM THE WASH STATION. ALL REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND ALL RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT. THIS IS A SINGLE EVENT INVOLVING MULTIPLE PT SAMPLES. THERE WERE NO REPORTS OF ANY ADVERSE EVENT, CHANGES TO PT CARE OR ANY INDICATION THAT MEDICAL INTERVENTION WAS NEEDED TO PREVENT OR PRECLUDE ADVERSE 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) ON (B)(6) 2009, IN REGARDS TO ERRONEOUSLY HIGH ACCUTNI RESULTS OBTAINED FROM A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TWO PTS. THE INITIAL ERRONEOUSLY ELEVATED ACCUTNI RESULT WERE NOT REPORTED OUTSIDE THE LAB. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN NORMAL REFERENCE RANGE. THERE ARE NO 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.

    Additional Manufacturer Narrative · 2

    FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE ON (B)(4) 2009. THE FSE REPLACED THE SAMPLE PROBE AND REMOVED GEL FROM THE WASH STATION. ALL REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND ALL RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT. THIS IS A SINGLE EVENT INVOLVING MULTIPLE PT SAMPLES. THERE WERE NO REPORTS OF ANY ADVERSE EVENT, CHANGES TO PT CARE OR ANY INDICATION THAT MEDICAL INTERVENTION WAS NEEDED TO PREVENT OR PRECLUDE ADVERSE 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 · 2

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) ON (B)(6) 2009, IN REGARDS TO ERRONEOUSLY HIGH ACCUTNI RESULTS OBTAINED FROM A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TWO PTS. THE INITIAL ERRONEOUSLY ELEVATED ACCUTNI RESULT WERE NOT REPORTED OUTSIDE THE LAB. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN NORMAL REFERENCE RANGE. THERE ARE NO 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 86 YR ACCESS ACCUTNI
    2 70 YR ACCESS ACCUTNI