BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2252945 · Received September 9, 2011

    Report

    Report Number
    2122870-2011-03558
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    March 3, 2009
    Report Date
    March 3, 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

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE ON (B)(6) 2009 TO INVESTIGATE THE EVENT. THE FSE INSPECTED THE INSTRUMENT AND FOUND THAT TWO OF THE FOUR REAGENT PIPETTORS HAD BEEN DISABLED. THE FSE INSPECTED AND CLEANED ALL REAGENT PIPETTORS, THE SAMPLE PROBE, ALL WASH STATIONS, DISPENSE PROBES AND WASH WHEEL. THE FSE REPLACED THE DUCK BILL VALVE, ASPIRATE PROBES AND PERI-PUMP TUBING. THE FSE CLEANED AND LUBRICATED ALL GUIDE RAILS. THE FSE RAN A HIGH SENSITIVITY SYSTEM CHECK AND A ROUTINE SYSTEM CHECK, BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. ALSO, A TEN REPLICATE ACCUTNI PRECISION TEST WAS PERFORMED AND PASSED WITHIN THE ASSAY PRECISION CLAIMS. THE FSE VERIFIED ALL REPAIRS PER ESTABLISHED PROCEDURES AND ALL RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. ALTHOUGH SOME HARDWARE ISSUES WERE ADDRESSED BY THE FSE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. THIS IS 5 OF 12 SEPARATE MDR REPORTS RELATED TO 12 PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS: MDR 2122870-2011-03554, MDR 2122870-2011-03555, MDR 2122870-2011-03556, MDR 2122870-2011-03557, MDR 2122870-2011-03558, MDR 2122870-2011-03559, MDR 2122870-2011-03560, MDR 2122870-2011-03561, MDR 2122870-2011-03562, MDR 2122870-2011-03563, MDR 2122870-2011-03564, MDR 2122870-2011-03565 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 ACCU TNI (TROPONIN I) RESULTS GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TWELVE PTS. THE CUSTOMER ONLY PROVIDED RESULTS FOR 4 PTS. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE 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 ACCESS IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI