BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOLERT

    MDR report key: 18708 · Received January 4, 1995

    Report

    Report Number
    MW1004647
    Event Type
    Malfunction
    Date Received
    January 4, 1995
    Manufacturer
    MERIDIAN DIAGNOSTICS, INC.
    Product Code
    LJN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO AN ARTICLE PUBLISHED BY RPTR, 38 CHILDREN (AGES 18 MONTHS TO 17 YEARS) WHO WERE DIAGNOSED WITH ACUTE IM USING THE TEST DURING THE PERIOD 10/92 TO 8/93. EIGHTY-THREE PERCENT OF THESE CHILDREN HAD NO EVIDENCE OF EPSTEIN-BARR VIRUS INFECTION ON SUBSEQUENT INVESTIGATION. THE FALSE POSITIVE RESULTS OF THE TEST COULD NOT BE EXPLAINED ON THE BASIS OF ELEVATED ANTIBODY TITERS TO EITHER CYTOMEGALOVIRUS OR BORRELIA BURGDORFERI. CONCLUSION BY THE RPTR IS THAT THIS IS A POOR SCREENING TEST AND IS OF LITTLE APPARENT VALUE AS A DIAGNOSTIC TEST FOR ACUTE EPSTEIN-BARR VIRUS INFECTION IN PEDIATRIC PTS. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOLERT MONONUCLEOSIS TEST ELISA LJN MERIDIAN DIAGNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other