BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIASORIN LIASON XL HSV 1

    MDR report key: 16655410 · Received March 30, 2023

    Report

    Report Number
    MW5116139
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    June 20, 2022
    Report Date
    March 28, 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 AND 2 POSITIVE TEST ON THE DIASORIN HSV 1 AND 2 IGG TEST, (INDEX VALUE FOR HSV 1 = 5.14, INDEX VALUE FOR HSV 2 = 1.26), FOLLOWED UP WITH A WESTERN BLOT WHICH WAS NEGATIVE FOR BOTH HSV 1 AND 2. DATE GIVEN IS THE WESTERN BLOT CONFIRMATORY TEST. REFERENCE REPORT #MW5116140.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529059 DIASORIN LIASON XL HSV 1 ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-1 MXJ DIASORIN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Other