BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS INSTRUMENT

    MDR report key: 586110 · Received March 23, 2005

    Report

    Report Number
    3002769706-2005-00009
    Event Type
    Malfunction
    Date Received
    March 23, 2005
    Date of Event
    February 21, 2005
    Report Date
    March 23, 2005
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JZT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE VIDAS INSTRUMENT IS A DISCRETE WAVELENGTH FLUOROMETER. THE INSTRUMENT HAS 5 SECTIONS WITH 6 POSITIONS PER SECTION. THE POSITIONS OPERATE MECHANICALLY INDEPENDENT OF EACH OTHER AND EACH POSITION CONTAINS A SAMPLE. THE CUSTOMER REPORTED ONE POSITION TO BE OUT OF RANGE WHEN A QUALITY CONTROL TEST WAS RUN. THE CUSTOMER THEN DISCOVERED THAT ONE VIDAS FT4 ASSAY RESULT WAS FALSE. THE VIDAS FT4 ASSAY IS AN ELISA ASSAY FOR THE DETERMINATION OF HUMAN FREE THYROXINE (FT4) CONCENTRATION. THE TEST PROVIDED A RESULT OF 55 PMOL/1 INSTEAD OF 12.74 PMOL/1. THIS FALSE RESULT WAS REPORTED TO THE PHYSICIAN. NO ADVERSE EFFECTS ON TREATMENT OF THE PT WERE REPORTED TO BIOMERIEUX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIDAS INSTRUMENT DISCRETE WAVELENGTH FLUOROMETER JZT BIOMERIEUX, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other