BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIASORIN LIASON XL HSV 1 TYPE SPECIFIC ANTIBODY TEST

    MDR report key: 16808220 · Received April 24, 2023

    Report

    Report Number
    MW5116985
    Event Type
    Injury
    Date Received
    April 24, 2023
    Date of Event
    January 26, 2023
    Report Date
    April 20, 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 TWO HSV 1 POSITIVE TESTS (INDEX VALUES = 4.26 AND 2.80) AND TWO HSV 2 POSITIVE TESTS (INDEX VALUES = 1.56 AND 1.98) 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. REFERENCE REPORT: MW5116984, MW5116986 AND MW5116987.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613703 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 38 YR Male Other