BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1211506 · Received October 17, 2008

    Report

    Report Number
    2122870-2008-00327
    Event Type
    Other
    Date Received
    October 17, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 17, 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
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED INTO PLASTIC BD LITHIUM HEPARIN TUBES WITH GEL AND CENTRIFUGED AT 3,000 RPM FOR 6 MINUTES. THE SAMPLES WERE TESTED FROM THE PRIMARY TUBES. QC WAS WITHIN RANGE ON THE DAY OF THE EVENT. NO EVENTS WERE POSTED TO THE EVENT LOG. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED IN 2008: THE FSE PERFORMED HARDWARE EVALUATION AND CONDUCTED A DIAGNOSTIC TESTING WHICH FAILED. THE FSE COMPLETED AND VERIFIED ALIGNMENTS FOR SAMPLE AND REAGENT PIPETTORS, AND THEN REPEATED AND DIAGNOSTIC TESTING WHICH FAILED AGAIN. THE FSE REPLACED PERI-PUMP TUBING AND THE DIAGNOSTIC TESTING MEET SPECIFICATIONS. THE FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MET PERFORMANCE SPECIFICATIONS. THE FSE WENT BACK TO THE L A DAY LATER: THE FSE COMPLETED DIAGNOSTIC TESTING WHICH FAILED. THE FSE VERIFIED ULTRASONICS AND ALIGNMENTS ON FAILED PIPETTORS AND VERIFIED ASPIRATION. THE FSE REPLACED PERI-TUBING AND ASPIRATION TESTING PASSED. THE FSE REPLACED THE DUCK BILL AND ROTATED ASPIRATE PROBES. THE DIAGNOSTIC TESTING PASSED AND VERIFICATION OF QC WAS ACCEPTABLE. THE HARDWARE ISSUES ADDRESSED BY THE FSE MAY HAVE CONTRIBUTED TO THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TWO (2) PT SAMPLES. PT A SAMPLE WAS TESTED FOR ACCU TNI AND RESULTS WERE 0.50NG/ML AND 0.08NG/ML. THE SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT AND TWO RESULTS OF 0.03NG/ML WERE OBTAINED. PT B SAMPLE GAVE RESULT OF 0.51NG/ML AND 0.16NG/ML. THE SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT AND TWO RESULTS OF 0.02NG/ML WERE OBTAINED. THE RESULTS WERE NOT REPORTED OUT OF THE LAB. IT IS UNK IF THERE WAS AN EFFECT TO PT IN CONNECTION TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA