BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS

    MDR report key: 331767 · Received May 8, 2001

    Report

    Report Number
    1950204-2001-00005
    Event Type
    Malfunction
    Date Received
    May 8, 2001
    Date of Event
    February 28, 2001
    Report Date
    May 8, 2001
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JZT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED MFR'S SUPPORT DEPARTMENT TO REPORT FALSE NEGATIVE RUBELLA TEST RESULTS ON THE VIDAS INSTRUMENT WHEN THE ASSAY WAS RUN IN ONE OF THE INSTRUMENT'S 30 POSITIONS, SPECIFICALLY SECTION B, CHANNEL 5. FIELD SERVICE WAS DISPATCHED AND REPLACED THE PUMP IN THAT POSITION. FURTHER ANALYSIS OF THE PUMP INDICATES THAT THE TUBES WITHIN THE PUMP WERE CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21070 VIDAS IMMUNOFLUROMETER EQUIPMENT JZT BIOMERIEUX, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *