BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTA FLASH H-TTG IGA

    MDR report key: 6584659 · Received May 19, 2017

    Report

    Report Number
    MW5069924
    Event Type
    Injury
    Date Received
    May 19, 2017
    Date of Event
    April 17, 2017
    Report Date
    May 19, 2017
    Manufacturer
    INOVA DIAGNOSTICS, INC
    Product Code
    MVM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEVERAL COMPLAINTS HAVE BEEN RECEIVED BY THE LABORATORY WHERE THE INOVA QUANTA FLASH HUMAN TISSUE TRANSGLUTAMINASE IGA TESTING DID NOT FIT THE CLINICAL PICTURE OR THERE WERE NEGATIVE RESULTS BY OTHER REFERENCE LABORATORIES. DATES OF USE: (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: AID IN THE DIAGNOSIS OF THE GLUTEN SENSITIVE ENTEROPATHIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361351 QUANTA FLASH H-TTG IGA AUTOANTIBODIES, ENDOMYSIAL (TISSUE TRANSGLUTAMINASE MVM INOVA DIAGNOSTICS, INC 1059
    361352 QUANTA FLASH H-TTG IGA AUTOANTIBIOTICS, ENDOMYSIAL (TISSUE TRANSGLUTAMINASE) MVM INOVA DIAGNOSTICS, INC 1292

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR