BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS

    MDR report key: 351841 · Received September 12, 2001

    Report

    Report Number
    1950204-2001-00014
    Event Type
    Malfunction
    Date Received
    September 12, 2001
    Date of Event
    September 5, 2001
    Report Date
    September 12, 2001
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JZT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED OF OBTAINING THREE INCORRECT RESULTS. FIELD SVC CONFIRMED PUMP FAILURE AND REPLACED THE PUMP. U.S. ENGINEERING CONFIRMED THAT THE PUMP WAS CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41483 VIDAS IMMUNOFLUROMETRIC EQUIPMENT JZT BIOMERIEUX, INC. VIDAS 30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *