inforMED
MalfunctionQLX

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

Received Nov 5, 2025 · Event occurred Aug 23, 2025

Report 23692525 · MDR key 23692525

Device

Generic name

Nucleic Acid Amplification Test For The Quantitation For Epstein-barr Virus (ebv

Manufacturer

Roche Diagnostics

Product problems

  • No Apparent Adverse Event
  • No Apparent Adverse Event

Patient

40 YR · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

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.