BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1022615 · Received March 31, 2008

    Report

    Report Number
    2122870-2008-00099
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 31, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS DURING THE TIME OF THE EVENT. NO ERRORS WERE POSTED TO THE EVENT LOG. THE SPECIMENS WERE COLLECTED IN 13 X 75 PLASTIC, BD LITHIUM HEPARIN TUBES WITH NO GEL. THE SAMPLES WERE CENTRIFUGED AT 3,500 RPM FOR 10 MINUTES AT ROOM TEMPERATURE. PER CUSTOMER, THE SAMPLE APPEARANCE WAS UNREMARKABLE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE PERFORMED DIAGNOSTIC TESTING WHICH PARTIALLY FAILED. THE FSE PERFORMED A PREVENTIVE MAINTENANCE (PM) TO THE INSTRUMENT. THE FSE PERFORMED ALIGNMENTS: ON WASH CAROUSEL, ON ALL PROBES, AND ON THE REAGENT PIPETTORS. THE FSE REMOVED AND CLEANED WASH WHEEL. THE FSE REPLACED WASH PUMPS. THE FSE RERAN DIAGNOSTIC TESTING WHICH PASSED. CUSTOMER RAN QC AND PATIENTS' SAMPLES, AND SYSTEM PERFORMED WITHIN SPECIFICATIONS. BASED ON AVAILABLE INFORMATION, THE CUSTOMER IS NOW REPEATING ALL ACCU TNI RESULTS TO CONFIRM ACCURACY. 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 ERRONEOUSLY HIGH TROPONIN (ACCU TNI) RESULTS THAT WERE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR A SINGLE PATIENT. THE INITIAL ACCU TNI RESULT WAS 1.91NG/ML AND 2.22NG/ML UPON REFLEX TEST. THE RESULTS WERE REPORTED OUT OF THE LAB AND QUESTIONED BY A PHYSICIAN. THE ORIGINAL SAMPLE WAS RETESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND A RESULT OF 0.26NG/ML WAS OBTAINED. A FRESH SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED ON THE DIFFERENT INSTRUMENT AND AN ACCU TNI RESULT WAS 0.23NG/ML. THE CUSTOMER DID NOT REPORT PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH 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