BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1200303 · Received October 1, 2008

    Report

    Report Number
    2122870-2008-00305
    Event Type
    Other
    Date Received
    October 1, 2008
    Date of Event
    September 8, 2008
    Report Date
    October 1, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED INTO BD LITHIUM HEPARIN TUBES AND CENTRIFUGED AT 3,000 RPM FOR 10 MINUTES. QC WAS TESTED PRIOR TO AND FOLLOWING THE EVENT AND PASSED. A SYSTEM CHECK WAS COMPLETED IN 2008 AND RESULTS MET SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND ON-SITE NINE DAYS LATER: FSE CLEANED THE SAMPLE AND REAGENT PIPETTORS AND PERFORMED CARRYOVER TESTING WHICH FAILED. FSE PERFORMED ALIGNMENTS TO SAMPLE PROBE, CLEANED THE SAMPLE PROBE WASH TOWER, AND REPEATED CARRYOVER TESTING WHICH THEN PASSED. FSE COMPLETED 3 LEVELS OF CARDIAC CONTROLS WHICH ALL PASSED. FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE, A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY ELEVATED ACCU-TNI RESULT GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. A PATIENT SAMPLE WHEN TESTED FOR ACCU-TNI GAVE A RESULT OF 2.2 NG/ML. UPON REPEAT IT GAVE A RESULT OF 0.18 NG/ML. TWO SAMPLES FROM THIS PATIENT HAD BEEN TESTED ON AN EARLIER DATE AND THE RESULTS WERE 0.17 AND 0.45 NG/ML WHICH WERE WITHIN THE RISK STRATIFICATION RANGE. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE HAS BEEN NO REPORT OF CHANGE TO PATIENT TREATMENT RECEIVED BY BCI TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA