BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MY LAB BOX HSV 2 TEST KIT

    MDR report key: 19142185 · Received April 19, 2024

    Report

    Report Number
    MW5153978
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    April 4, 2024
    Report Date
    April 16, 2024
    Manufacturer
    UNK
    Product Code
    OQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I ORDERED AN STD TEST KIT FROM MY LAB BOX WHICH INCLUDES AN HSV 2 TEST. I GOT POSITIVE WITH NO INDEX NUMBER. IT TOOK ME 4 DAYS FOR THEM TO EMAIL ME THE INDEX NUMBER. I THINK THEY HID IT AND ARE BANKING ON CUSTOMERS' IGNORANCE. SEVERAL PEOPLE ON TRUST PILOT HAVE HAD THE SAME EXPERIENCE. THEIR WEBSITE SAYS ONCE YOU TEST POSITIVE FOR HSV 2 THERE IS NO NEED TO RETEST. AFTER READING THE FDA AND CDC WEBSITES AND GOING ON REDDIT DEEP DIVES I LEARNED ABOUT FALSE POSITIVES. THE ASSIGNED PHYSICIAN WAS EAGER TO PRESCRIBE ME MEDICATION AND TOLD ME THE TEST WAS 90% ACCURATE. NOT TRUE. I WAS DEPRESSED AND SUICIDAL FOR 10 DAYS UNTIL I GOT A FOLLOW-UP TEST AT (B)(6) THAT CONFIRMED I DID NOT HAVE HSV2. I DO NOT BELIEVE MY LAB BOX SHOULD BE SELLING THIS TEST AS I HAVE RECENTLY LEARNED THAT IT IS NOT A PART OF THE REGULAR STD PANEL BECAUSE OF THE PSYCHOLOGICAL DAMAGE A FALSE POSITIVE CAN CAUSE. THEY ARE CLEARLY IN IT FOR THE MONEY AND NOT FOR THE CLIENT'S WELL-BEING. I LOST (B)(6) DOLLARS, SLEEP, AND WEIGHT FROM NOT EATING DUE TO THIS MISINFORMATION AND CARELESSNESS. I DO NOT WANT THIS TO HAPPEN TO ANYONE ELSE. PLEASE MAKE THEM REMOVE THIS TEST FROM THEIR WEBSITE ASAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1842037 MY LAB BOX HSV 2 TEST KIT HERPES SIMPLEX VIRUS NUCLEIC ACID AMPLIFICATION ASSAY OQO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other UBER BOX