BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPSTEIN BARR VIRUS DNA, QN REAL TIME PCR,PLASMA

    MDR report key: 22916536 · Received August 28, 2025

    Report

    Report Number
    MW5175381
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Report Date
    August 23, 2025
    Manufacturer
    QUEST DIAGNOSTICS
    Product Code
    QLX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I ORDERED A QUANTITATIVE TEST FROM QUEST DIAGNOSTICS, AFTER DOING A HOME TEST FINGER PRICK BLOOD TEST FOR TO SEE IF I HAD EPSTEIN-BARR VIRUS STILL AND THE FINGERPRINT TEST CAME BACK POSITIVE BUT WHEN I ORDERED A QUALITATIVE TEST TO MEASURE HOW MANY COPIES PER MILLILITER OF THE VIRUS I HAD IN MY BLOOD THEY SIMPLY CAME BACK WITH ONE DAY LATER SAYING THAT IT WAS NEGATIVE AND THERE WAS NO COPIES PER MILLILITER EVEN REPORTED. I PAID OUT OF POCKET $200, AND THEY DIDN'T EVEN RUN THE TEST. WHY ARE CONSUMERS NOT ALLOWED TO DO THEIR OWN DIAGNOSTICS IF THE LABS THAT WE ARE REQUIRED TO USE AREN'T TRUSTWORTHY?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2223262 EPSTEIN BARR VIRUS DNA, QN REAL TIME PCR,PLASMA NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF EPSTEIN-BARR VIRUS (EBV) QLX QUEST DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female