BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS

    MDR report key: 351846 · Received September 13, 2001

    Report

    Report Number
    1950204-2001-00013
    Event Type
    Malfunction
    Date Received
    September 13, 2001
    Date of Event
    July 23, 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 OVERSEAS CALLED TO COMPLAIN ABOUT A INCORRECT PT RESULT. FIELD SVC EXAMINED THE INSTRUMENT AND DETERMINED THAT THE PUMP NEEDED TO BE REPLACED. THE PUMP WAS RETURNED TO CO'S OVERSEAS HEADQUARTERS AS BEING POSSIBLY CLOGGED. CO'S ENGINEERS CONFIRMED THAT THE PUMP WAS CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41876 VIDAS IMMUNOFLUROMETRIC EQUIPMENT JZT BIOMERIEUX, INC. VIDAS 30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *