BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDEX ROTA KIT 2

    MDR report key: 147761 · Received February 5, 1998

    Report

    Report Number
    MW1012955
    Event Type
    Malfunction
    Date Received
    February 5, 1998
    Manufacturer
    BIOMERIEUX VITEK, INC.
    Product Code
    LIQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A KIT CALLED SLIDEX ROTA KIT 2, USED FOR DETECTING THE ANTIGEN OF THE GROUP OF VIRUSES CALLED ROTAVIRUS, AND MARKETED BY BIOMERIEUX VITEK, WITH OFFICES AT 595 ANGIUM DRIVE, HAZELWOOD, MO 63042, STATES IN ITS PACKAGE INSERT "DO NOT INTERCHANGE REAGENTS BETWEEN DIFFERENT LOT NUMBERS. HOWEVER, THE KITS CONTAIN THREE VIALS EACH WITH A DIFFERENT LOT NO, AND THE BOX CONTAINS A YET DIFFERENT NUMBER. HOW IS THE CUSTOMER TO KNOW WHETHER THE VIALS WERE ASSEMBLED CORRECTLY BY THE MFR IF THERE ARE NO CLUES AS TO WHICH NUMBERS GO TOGETHER AND WHICH ONES DO NOT MATCH? AT THE VERY LEAST, THE BOX OR THE PACKAGE INSERT SHOULD GIVE A KEY TO THE LOT NUMBERS OF THE VIALS THAT BELONG IN THAT BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIDEX ROTA KIT 2 ROTAVIRUS ANTIGEN DETECTOR KIT LIQ BIOMERIEUX VITEK, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other