BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS

    MDR report key: 351836 · Received September 13, 2001

    Report

    Report Number
    1950204-2001-00015
    Event Type
    Malfunction
    Date Received
    September 13, 2001
    Date of Event
    August 28, 2001
    Report Date
    September 13, 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 CALLED EUROPEAN OFFICE TO COMPLAIN OF INCORRECT RESULTS USING CO'S RBG ASSAY. FIELD SVC WAS DISPATCHED AND AFTER TESTING THE PUMP REPLACED THE PUMP. FURTHER ANALYSIS BY ENGINEERING STAFF REVEALED THAT THE PUMP WAS CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41977 VIDAS IMMUNOFLUROMETRIC EQUIPMENT JZT BIOMERIEUX, INC. VIDAS 30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *