BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTIBODY DESMIN FOR VENTANA NEXES INSTRUMENT

    MDR report key: 502642 · Received December 10, 2003

    Report

    Report Number
    MW1030492
    Event Type
    Malfunction
    Date Received
    December 10, 2003
    Date of Event
    October 1, 2003
    Report Date
    October 1, 2003
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    MVU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING REGISTRATION OF REAGENT, COMPUTER STATED NEW UNOPENED ANTIBODY HAD EXPIRED 08/2003, WHEN THE CONTAINER READS 04-JUNE-04. THE COMPANY IS SHIPPING A NEW BUTTON TO REGISTER PRODUCT AND A NEW BAR CODE LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTIBODY DESMIN FOR VENTANA NEXES INSTRUMENT * MVU VENTANA MEDICAL SYSTEMS, INC. NEXES - 4 MODULES 21440B
    2 ANTIBODY DESMIN FOR VENTANA NEXES INSTRUMENT * MVU VENTANA MEDICAL SYSTEMS, INC. NEXES - 4 MODULES 21440B
    3 ANTIBODY DESMIN FOR VENTANA NEXES INSTRUMENT * MVU VENTANA MEDICAL SYSTEMS, INC. NEXES - 4 MODULES 21440B
    4 ANTIBODY DESMIN FOR VENTANA NEXES INSTRUMENT * MVU VENTANA MEDICAL SYSTEMS, INC. NEXES - 4 MODULES 21440B

    Patients

    Seq Age Sex Outcome Treatment
    1 *