BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 IMMUNOASSAY SYSTEM

    MDR report key: 2183593 · Received July 8, 2011

    Report

    Report Number
    2122870-2011-02124
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SVC ENGINEER (FSE) WAS ONSITE ON (B)(4) 2008. THE FSE PERFORMED PREVENTATIVE MAINTENANCE (PM) ON THE INSTRUMENT. THE FSE REPLACED THE SAMPLE PROBE BECAUSE IT APPEARED WORN OUT. THE FSE PERFORMED HIGH SENSITIVITY SYS CHECK, ROUTINE SYS CHECK, CARRYOVER AND A 50 REPLICATE PRECISION TEST WITH ACCUTNI LOW QUALITY CONTROL (QC) FOR VERIFICATION. ALL TESTS MET SET SPECS. THE FSE VERIFIED ALL REPAIRS PER ESTABLISHED PROCEDURES AND THE RESULTS MET PUBLISHED PERFORMANCE SPECS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT. THIS IS ONE OF FIVE SEPARATE MDR REPORTS RELATED TO FIVE PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS MDR 2122870-2011-02125, 02126, 02127, 02140 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN I) RESULTS GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYS FOR FIVE PTS. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LAB. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN NORMAL REFERENCE RANGE. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO PT TREATMENT. THERE IS NO INDICATION OF AN ADVERSE EVENT OR INDICATION OF ANY MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI