BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS

    MDR report key: 342567 · Received July 13, 2001

    Report

    Report Number
    1950204-2001-00011
    Event Type
    Malfunction
    Date Received
    July 13, 2001
    Date of Event
    May 28, 2001
    Report Date
    July 11, 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 DETECTED INCORRECT RESULTS ON AN FT4 ASSAY AND CALLED BIOMEREIEUX FOR SERVICING. THE PUMP WAS REPLACED BY FIELD SERVICE. FURTHER ANALYSIS OF THE PUMP INDICATED THAT ONE OF THE CHANNELS IN THE PUMP WAS CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32230 VIDAS IMMUNOFLUROMETRIC EQUIPMENT JZT BIOMERIEUX INC. VIDAS 30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *