BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1156116 · Received September 4, 2008

    Report

    Report Number
    2122870-2008-00271
    Event Type
    Other
    Date Received
    September 4, 2008
    Date of Event
    August 11, 2008
    Report Date
    September 4, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIMEN WAS LI HEPARIN PLASMA AND WAS SPUN AT 3800 RPM FOR 5 MINUTES. QC DATA SUPPLIED SHOWS ASSAY WAS REPORTING WITHIN EXPECTED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS ON SITE IN 2008: FSE MADE SOME ADJUSTMENTS TO THE ALIGNMENTS. FSE PERFORMED HARDWARE VERIFICATION. FSE VERIFIED THE 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 ERRONEOUSLY ELEVATED ACCUTNI RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. CUSTOMER TESTED A PATIENT SAMPLE FOR ACCUTNI AND OBTAINED RESULTS OF 1.75 AND 1.57 NG/ML. WHEN TESTED AT A LATER TIME, THE SAMPLE GAVE RESULTS OF 0.02 AND 0.01NG/ML. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. 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