FDA Adverse Event Malfunction Summary report: N

HSV-1 & HSV-2

MDR report key: 21933793 · Received April 30, 2025

Report

Report Number
MW5169629
Event Type
Malfunction
Date Received
April 30, 2025
Date of Event
April 13, 2025
Report Date
April 26, 2025
Manufacturer
UNK
Product Code
OQO
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

FIRST LET ME START BY 'SAYING THAT I HAVE SEVERE MENTAL HEALTH PROBLEMS, IN FACT I AM ON DISABILITY FOR MY MENTAL HEALTH. WELL FIRSTLY, I DID NOT EVEN KNOW MY DR WAS TESTING ME FOR HERPES, WHEN I ASKED WHAT THE SWAB WAS, SHE SAID, "IT'S TO TEST FOR INFECTIONS." TO MY SURPRISE, A COUPLE DAYS LATER I GET A CALL ONE THING I EXPECTED YEAST IS PRESENT. HOWEVER, THEY THEN PROCEEDED TO TELL ME I TESTED POSITIVE FOR HSV-2. I WAS DISTRAUGHT HAVE BEEN WITH MY BOYFRIEND FOR ALMOST A DECADE, MY LAST HERPES TEST BEING 2017 (WE WERE TOGETHER THEN). I WAS MET WITH COMPLETE MISAPPROPRIATION OF COMPASSION WHEN TOLD "YOUR HERPES TEST CAME BACK POSITIVE." THERE WAS NO TYPE OF EMPATHY INVOLVED. I THEN ASKED IF THERE WAS ANY CHANCE IT COULD BE A FALSE POSITIVE AND WAS BLUNTLY TOLD "NO." (MY FRIEND RECENTLY HAD A FALSE POSITIVE AS WELL.) I THEN PROCEED LATER THAT DAY TO GO TO THE EMERGENCY ROOM. THERE, THE DR WAS EVEN HESITANT TO DO THE TEST BECAUSE "IT'S VERY UNLIKELY TO GET A FALSE POSITIVE." HE EVENTUALLY AGREED AND TO MY SURPRISE TODAY I WOKE UP TO A NEGATIVE HERPES RESULT. I WAS RELIEVED; HOWEVER, MY LIFE WAS TURNED UPSIDE DOWN IN THE PROCESS. I EVEN CONTEMPLATED SUICIDE (OBVIOUSLY I DIDN'T DO THAT) BUT THIS MISTAKE COULD HAVE VERY WELL COST ME MY LIFE. HEALTH CARE WORKERS AT BOTH (B)(6), NEED TO BE BETTER TRAINED TO HAVE COMPASSION FOR PEOPLE THAT ARE IN THIS SITUATION BECAUSE YOU NEVER KNOW WHAT THE PT IS GOING THROUGH MENTALLY AND PHYSICALLY. ALSO, THEY SHOULD ADVISE YOU OF NEXT STEPS TO BE TAKEN AFTER A POSITIVE RESULT. THEY ALSO NEED TO BE REMINDED THAT FALSE POSITIVES DO HAPPEN AND ARE MORE PREVALENT WITH THOSE WITH LOW RISK FACTORS. THIS INFO WAS NOT PROVIDED TO ME AS IT WAS TESTED AT AN UNK LABORATORY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1414082 HSV-1 & HSV-2 HERPES SIMPLEX VIRUS NUCLEIC ACID AMPLIFICATION ASSAY OQO UNK

Patients

Seq Age Sex Outcome Treatment
1 29 YR Female Other ATORVASTATIN | GABAPENTIN| HYDROXYZINE PAM| L-TYROSINE| LAMICTAL | LEVOTHYROXINE| METOPROLOL | PANTOPRAZOLE| PROPRANOLOL | REXULTI | ROPINIROLE | TIZANIDINE| TRINTELLIX| VENTOLIN | VITAMIN B COMPLEX| VITAMIN D3| VYVANSE| WELLBUTRIN XL