BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HSV 2 IGG TEST

    MDR report key: 12460772 · Received September 10, 2021

    Report

    Report Number
    MW5103870
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    August 28, 2021
    Report Date
    September 8, 2021
    Manufacturer
    UNK
    Product Code
    MXJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 1

    IGG TEST FOR (B)(6) GAVE FALSE (B)(6) RESULT COMPARED TO THE (B)(6) WESTERN BLOT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354816 HSV 2 IGG TEST ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2 MXJ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR