BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUEST 10 PANNEL STD SCREENING (HSV 2 SPECIFIC)

    MDR report key: 18667587 · Received February 7, 2024

    Report

    Report Number
    MW5151157
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    October 1, 2023
    Report Date
    February 4, 2024
    Manufacturer
    QUEST DIAGNOSTICS
    Product Code
    MYF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SEVERE MENTAL IMPACT. LOSS OF SLEEP AND APPETITE. I RECEIVED A FALSE POSITIVE AFTER CALLING QUEST TO SEE WHAT MY RESULTS WHERE I INITIALLY TESTED 1.46 H FOR HSV 2(HERPES SIMPLEX VIRUS 2) WHICH SENT ME INTO A DEEP DEPRESSION. THE REP TOLD ME THE TEST WAS SENT FOR THE INHIBITION ASSAY AND I SHOULD HEAR BACK IN A FEW DAYS. ONE WEEK AFTER I GOT MY RESULTS BACK SHOWING NEGATIVE. I DIDN'T SLEEP OR EAT AND HEAD VERY DEEP DEPRESSION UNTIL I "GKT" RESULTS BACK. I AM STILL SUFFERING FROM PARANOIA AND ANXIETY DUE TO THIS TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365021 QUEST 10 PANNEL STD SCREENING (HSV 2 SPECIFIC) ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2 MYF QUEST DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Other MULTIVITAMIN | VYVANSE