BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIAISON HSV-2 TYPE SPECIFIC IGG

    MDR report key: 19939061 · Received August 8, 2024

    Report

    Report Number
    2182595-2024-00001
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    May 7, 2024
    Report Date
    August 7, 2024
    Manufacturer
    DIASORIN INC
    Product Code
    MYF
    UDI-DI
    08056771600101
    PMA / PMN Number
    K081687
    Removal / Correction Number
    RES# 93741
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE TESTING DATES ARE UNKNOWN, IT IS NOT CLEAR THAT THE LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY WAS USED TO TEST THIS PATIENT. US DIAGNOSTIC LABORATORY STARTED USING THE LIAISON ASSAY IN 2017 AND BECAUSE TESTING SITE AND DATES ARE UNKNOWN, NO CONCLUSION CAN BE DRAWN RELATED TO SPECIFIC PRODUCT OR LOTS THAT MAY HAVE BEEN USED. HOWEVER, AS THE PATIENT IS ALLEGING FALSE POSITIVE RESULTS OVER THE LAST 10 YEARS, IT IS POSSIBLE THAT THE PATIENT WAS TESTED USING A LOT INVOLVED IN THE (B)(6) 2023 RECALL RELATED TO INCREASED FREQUENCY OF EQUIVOCAL AND FALSE POSITIVE RESULTS.

    Description of Event or Problem · 0

    A US DIAGNOSTIC LABORATORY RECEIVED A MEDWATCH REPORT, MW154728, DATED 05/07/2024 FROM A PATIENT STATING, "BLOOD TEST HSV 2 IGG (HERPES SIMPLEX VIRUS 2 TYPE-SPECIFIC ANTIBODY), AB HERPESSELECT HAS BEEN PRODUCING FALSE POSITIVES FOR ME OVER THE COURSE OF 10 YEARS WITH VALUES OF 1.36-1.83.I RECENTLY LEARNED ABOUT THE HIGH RATES OF FALSE POSITIVES ON LOW POSITIVE RESULTS (1.10-3.00) AND AFTER ASSERTIVELY REQUESTING A CONFIRMATORY TEST - HSV 2 IGG INHIBITION ASSAY BECAUSE NONE OF THE 3 PROVIDERS I SPOKE WITH UNDERSTOOD THE RATE OF FALSE POSITIVES, I RECEIVED A NEGATIVE ON THE INHIBITION ASSAY. THIS HAS CAUSED YEARS OF INTERPERSONAL ISSUES, ANXIETY, AND DEPRESSION DUE TO SOCIAL STIGMA AROUND HSV2". ADDITIONAL INFORMATION WAS RECEIVED ON 6/20/2024 FOR REPORT MW5154728 TO CHANGE THE MANUFACTURER TO DIASORIN MOLECULAR LLC. ON 07/08/2024 DIASORIN MOLECULAR DETERMINED THAT THE RESULTS FROM THE LAST 10 YEARS, MAY INCLUDE RESULTS NOT ONLY FROM THE DIASORIN MOLECULAR HERPESELECT EIA ASSAY, BUT ALSO THE LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396261 LIAISON HSV-2 TYPE SPECIFIC IGG ENZYME LNKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2 MYF DIASORIN INC 08056771600101

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female