BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIASORIN LIASON XL HSV 1 TYPE SPECIFIC ANTIBODY TEST

    MDR report key: 16663679 · Received March 31, 2023

    Report

    Report Number
    MW5116215
    Event Type
    Injury
    Date Received
    March 31, 2023
    Date of Event
    March 7, 2022
    Report Date
    March 29, 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 2 POSITIVE TEST ON THE DIASORIN HSV 1 AND 2 IGG TEST, (INDEX VALUE = 3.64), FOLLOWED UP WITH A WESTERN BLOT WHICH WAS NEGATIVE FOR HSV 1 AND INDETERMINATE FOR HSV 2. DATE GIVEN IS THE WESTERN BLOT CONFIRMATORY TEST. REFERENCE REPORT: MW5116216.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242136 DIASORIN LIASON XL HSV 1 TYPE SPECIFIC ANTIBODY TEST ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-1 MXJ DIASORIN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male Other