BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1188388 · Received October 2, 2008

    Report

    Report Number
    2122870-2008-00310
    Event Type
    Other
    Date Received
    October 2, 2008
    Date of Event
    September 15, 2008
    Report Date
    October 2, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED INTO PLASTIC SERUM SEPARATOR TUBES. THE SAMPLES WERE AT LEAST 30 MINS OLD AT THE TIME OF TESTING. THE SPECIMENS WERE NOT RE-CENTRIFUGED PRIOR TO REPEAT TESTING. QC WAS NOT SUPPLIED. HOWEVER, THE CUSTOMER STATED QC WAS TESTED AFTER THE EVENT AND WAS OUT OF RANGE HIGH. CUSTOMER ATTEMPTED TO REPEAT QC, BUT RESULTS WERE STILL HIGH. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE INSPECTED THE INSTRUMENT AND OBSERVED LINE TO DISPENSE PROBE 3 WAS SEVERED BY WASH EJECTOR PLATE AND REPLACED. THE FSE PERFORMED A SYSTEM CHECK AND QC TESTING, AND ALL RESULTS PASSED. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. ALTHOUGH THE FSE ADDRESSED HARDWARE ISSUES, 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 COUTLER INC. (BCI) REGARDING ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR SEVERAL PATIENTS' SAMPLES. THE CUSTOMER WAS NOT CERTAIN OF THE TOTAL NUMBER OF PTS, BUT STATES THERE WAS A MINIMUM OF 4 PT SAMPLES FOR WHICH RESULTS WERE PROVIDED. THE INITIAL RESULTS WERE: 0.99 NG/ML, 1.67 NG/ML, 2.0 NG/ML AND 2.0 NG/ML FOR PT A-D RESPECTIVELY. THE SAMPLES WERE RE-TESTED ON THE DXI 800 INSTRUMENT AND THE FOLLOWING INFO WAS PROVIDED: "CUSTOMER NOT CERTAIN OF RESULTS, BUT STATES THEY WERE DISCORDANT". THE SAMPLES WERE TESTED ON A DIFFERENT INSTRUMENT AND ACCU TNI RESULTS OF "<0.1 NG/ML" WERE OBTAINED FOR ALL 4 PTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB, AND THERE WAS NO EFFECT TO PATIENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA