BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1211508 · Received October 17, 2008

    Report

    Report Number
    2122870-2008-00332
    Event Type
    Other
    Date Received
    October 17, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS ARE PLASMA IN LITHIUM HEPARIN TUBES WITH A GEL SEPARATOR AND CENTRIFUGED AT 3,000 RPM FOR 4 MINUTES. QC WAS WITHIN RANGE BEFORE THIS EVENT. CUSTOMER DID NOT QUESTION ANY OTHER SAMPLES OR ASSAYS AT THIS TIME. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 10/05/08: THE FSE PERFORMED A DIAGNOSTIC TESTING WHICH FAILED. THE FSE REPLACED THE ASPIRATE PROBE TUBING. THE FSE RAN DIAGNOSTIC AND CARRYOVER TESTING, AND ALL RESULTS PASSED WITHIN SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, NO CLEAR ROOT CAUSE HAS 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 ERRONEOUSLY ELEVATED TROPONIN (ACCU-TNI) RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR A SINGLE PATIENT SAMPLE. A PATIENT SAMPLE WAS TESTED FOR ACCU-TNI AND A RESULT OF 4.09 NG/ML WAS OBTAINED. THE SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT AND AN ACCU-TNI WAS 0.05 NG/ML. THE SAMPLE WAS THEN RE-TESTED ON THE DXI 800 INSTRUMENT AND REPEATED RESULT OF 4.90 NG/ML WAS REPORTED OUT OF THE LAB. THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS RE-TESTED ON THE DIFFERENT INSTRUMENT AND A RESULT OF 0.08 NG/ML WAS OBTAINED. A CORRECTED REPORT WAS SENT. A FRESH SAMPLE COLLECTED FROM THIS PATIENT WAS TESTED TWICE ON THE DXI 800 ANALYZER AND RESULTS WERE 0.32 NG.ML AND 0.22 NG/ML RESPECTIVELY. THE SAMPLE WAS ALSO TESTED ON THE DIFFERENT INSTRUMENT, BUT RESULTS WERE NOT SUPPLIED. THE CUSTOMER IS NOT CERTAIN IF PATIENT TREATMENT HAS BEEN AFFECTED.

    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