MAUDE Adverse Event Report: UNKNOWN HSV TESTING; ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2

Device Problem False Negative Result (1225)

Patient Problem Viral Infection (2248)

Event Date 01/03/2023

Event Type  Injury  

Event Description

I have been having intense hsv symptoms and have tested negative on 3 separate igg tests.I did not accept these results as the doctor said it can miss 8% of hsv2 and 30% of hsv1 infections.Even at 12 weeks of waiting i was still negative.I had to pay (b)(6) for a western blot confirmatory test to prove positive.This left me with extreme anxiety and stress as well as many mental problems as doctors continued to tell me i was fine when i knew i was not.I was not able to receive antivirals to help with symptoms as i was not "testing positive" when they were in fact false negatives.This is a serious matter.Having to wait 12 weeks is also crazy to me as that's 12 weeks i could have potentially spread it to other people if i did believe the tests.New testing for hsv that is accurate needs to be addressed immediately.(b)(6).

• Brand Name: HSV TESTING
• Type of Device: ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16185942
• MDR Text Key: 307670097
• Report Number: MW5114345
• Device Sequence Number: 3
• Product Code: MYF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/12/2023
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2023
• Patient Sequence Number: 1
• Treatment: MELATONIN.
• Patient Outcome(s): Disability
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White