BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS

    MDR report key: 331771 · Received May 8, 2001

    Report

    Report Number
    1950204-2001-00003
    Event Type
    Malfunction
    Date Received
    May 8, 2001
    Date of Event
    March 21, 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
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RAN A POSITIVE CONTROL IN CHANNEL 1 OF THE VIDAS INSTRUMENT. THE POSITIVE CONTROL FAILED AND THE CUSTOMER CALLED BIOMERIEUX TO REPORT THE PROBLEM. THE CUSTOMER WAS ADVISED TO PUT THE AFFECTED BAY OFF-LINE. FIELD SERVICE WENT TO THE SITE AND CONFIRMED THAT THE PUMP WAS NOT FUNCTIONING AND IT WAS REPLACED IN THE AFFECTED CHANNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21035 VIDAS IMMUNOFLUROMETER EQUIPMENT JZT BIOMERIEUX, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *