BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2172533 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-02009
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS ONSITE ON (B)(4) 2008, TO INVESTIGATE THE EVENT. THE FSE INSPECTED THE INSTRUMENT AND FOUND A WORN DUCKBILL AND SOME LINES FOR THE ASPIRATE AND DISPENSE PROBE TUBING WERE ROUTED TIGHTLY, POSSIBLY CAUSING BINDING. THE FSE REPLACED THE DUCKBILL AND CORRECTED THE ROUTING FOR THE ASPIRATE AND DISPENSE PROBE TUBING. THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK WHICH PASSED AND ALL CONTROLS WERE WITHIN SPECIFICATION. THE FSE FOLLOWED UP WITH THE CUSTOMER ON (B)(4) 2008 AND THE CUSTOMER STATED THAT THEIR LOW LEVEL QC HAD A RESULT OUT OF SPECIFICATION 3 STANDARD DEVIATIONS. THE FSE RETURNED TO THE SITE AND PERFORMED A PREVENTATIVE MAINTENANCE ON (B)(4) 2008. THE FSE FOUND THE PERI-PUMP WASH ROTOR FOR PIPETTOR #3 HAD A ROLLER THAT WAS SLIGHTLY BINDING AND THE VACUUM PUMP FOR PIPETTORS #1 AND #2 HAD KINKED LINES THAT WERE CORRECTED. THE FSE PERFORMED TESTING PER VERIFICATION PROCEDURES THAT PASSED SPECIFICATIONS. ALSO A PRECISION RUN WAS PERFORMED AND THE RESULTS PASSED WITHIN SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED BY THE FSE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. THIS IS ONE OF THREE SEPARATE MDR REPORTS RELATED TO THREE PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS 2122870-2011-02010, 2122870-2011-02011 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 ERRONEOUS ACCUTNI (TROPONIN I) RESULTS GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR THREE PTS. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN NORMAL REFERENCE RANGE. THE CUSTOMER INDICATED THAT TWO OF THE INITIAL ERRONEOUS 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