BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2152343 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-02028
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 19, 2008
    Report Date
    May 20, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS ONSITE (B)(4) 2008 TO (B)(4) 2008 TO INVESTIGATE THE EVENT. THE FSE INDICATED THE CUSTOMER PERFORMED A PRECISION RUN ON A TNI AND CK-MB WITH ALL THREE LEVELS OF CONTROLS AND RESULTS WERE WITHIN SPECIFICATION. THE FSE CHECKED THE MAINTENANCE RECORDS WHICH INDICATED THAT ASPIRATE PROBE/DISPENSE PROBE MAINTENANCE HAD NOT BEEN DONE SINCE 02/22/2008. THE FSE CHECKED SYSTEM CHECK RESULTS AND THEY WERE WITHIN SPECIFICATIONS. THE FSE PERFORMED HIGH SENSITIVITY SYSTEM CHECK WITH THE FOAM PORTION OF THE TEST FAILING. FURTHER INVESTIGATION BY THE FSE INDICATED THAT THE INSTRUMENT IS DUE FOR A PREVENTATIVE MAINTENANCE (PM). THE PM WAS COMPLETED BY THE FSE. THE FSE ADJUSTED AND REPAIRED PIPETTOR 4 ULTRASONIC'S, REPLACED CLOGGED AIR FILTER AND REPAIRED A LEAK IN THE QUICK CONNECTING FITTING FOR PIPETTOR 1. THE FSE PERFORMED A SYSTEM CHECK AND HIGH SENSITIVITY CHECK AFTER THE PM AND BOTH TESTS PASSED WITHIN SPECIFICATIONS. THE FSE VERIFIED REPAIRS PER ESTABLISHED PROCEDURES AND RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. ALTHOUGH, THE FSE ADDRESSED HARDWARE ISSUES, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. THIS IS ONE OF TWO SEPARATE MDR REPORTS RELATED TO TWO PATIENT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS 2122870-2011-02028, 02029 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 THRU OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ERRONEOUS ACCU TNI (TROPONIN 1) AND CK-MB RESULTS GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER RE-RAN THE SAMPLES AND THE RESULTS WERE IN THE NORMAL REFERENCE RANGE. THE INITIAL ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PATIENT 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| ACCESS CK-MB