BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIASORIN LIASON XL HSV 1

    MDR report key: 16768718 · Received April 18, 2023

    Report

    Report Number
    MW5116777
    Event Type
    Injury
    Date Received
    April 18, 2023
    Date of Event
    January 6, 2023
    Report Date
    April 14, 2023
    Manufacturer
    DIASORIN, INC.
    Product Code
    MXJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    117
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A HSV 1 POSITIVE TEST (INDEX VALUE = 3.97) AND A HSV 2 POSITIVE TEST (INDEX VALUE = 1.94) ON THE DIASORIN HSV 1 AND 2 IGG TEST, FOLLOWED UP WITH A WESTERN BLOT WHICH WAS NEGATIVE FOR HSV 1 AND 2. DATE GIVEN IS THE WESTERN BLOT CONFIRMATORY TEST. REFERENCING REPORT: MW5116778.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601457 DIASORIN LIASON XL HSV 1 ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-1 MXJ DIASORIN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Other