BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPSTEIN-BARR VIRUS DNA, QUANTITATIVE, REAL-TIME PCR, PLASMA

    MDR report key: 23692525 · Received November 5, 2025

    Report

    Report Number
    23692525
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    August 23, 2025
    Report Date
    November 5, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    QLX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    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 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 MILLIMETER OF THE VIRUS I HAVE IN MY BLOOD, THEY SIMPLY CAME BACK WITH ONE DAY LATER SAYING THAT IT WAS NEGATIVE AND THERE WAS NO COPIES PER MILLIMETER EVEN REPORTED. I PAID $(B)(6) OUT OF POCKET, 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? TEST RESULTS DID NOT DETECT EBV FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959184 EPSTEIN-BARR VIRUS DNA, QUANTITATIVE, REAL-TIME PCR, PLASMA NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION FOR EPSTEIN-BARR VIRUS (EBV QLX ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female