BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS

    MDR report key: 331768 · Received May 8, 2001

    Report

    Report Number
    1950204-2001-00004
    Event Type
    Malfunction
    Date Received
    May 8, 2001
    Date of Event
    March 22, 2001
    Report Date
    May 4, 2001
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JZT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE AS PART OF A WORLDWIDE CHECK FOR CLOGGED PUMPS ON VIDAS INSTRUMENTS. DURING ONE SUCH VISIT TO THE CUSTOMER BELOW BY A BIOMERIEUX FIELD SERVICE ENGINEER THE INSTRUMENT FAILED PERFORMANCE TESTING WHICH INDICATED THAT THE PUMP IN THE FAILING POSITION COULD BE CLOGGED. A CLOGGED PUMP CAN RESULT IN INACCURATE TEST RESULTS BEING REPORTED BY THE LABORATORY. THE PUMP WAS REPLACED BY THE FIELD SERVICE ENGINEER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21140 VIDAS IMMUNOFLUROMETRIC EQUIPMENT JZT BIOMERIEUX, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *