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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2024

Event Type  malfunction  

Event Description

I am dating polyamorously, and before a partner and i got sexually involved per their request due to a severely immunocompromised individual in their polyamorous connection i went ahead and tested for herpes simplex virus-1 and herpes simplex virus-2.Both of my igg tests resulted as positive, with index values at roughly 3.0.I have never had cold sores or genital lesions at all in my life.This resulted in partners hesitant to continue things with me, and other partners stopped talking to me entirely.I was worried my lips, my skin, my tears were dirty.When i reached out to my primary care physician they agreed i was positive, and it was left at that.It wasn't until i reached out to dr.(b)(6) and dr.(b)(6) that they talked about the possibility that my tests were false positives, and to seek confirmatory testing through the (b)(6).My pcp had the test done through (b)(6), which i later called (b)(6) who confirmed this is a different test, and also had the test done independently with dr.(b)(6) the test with dr.(b)(6) was not covered by insurance, and i would end up paying some (b)(6) out of pocket to have the test done.Later, when i called (b)(6) collections dept., they revealed to me that both tests done through pcp and dr.(b)(6) were the same test after all.All confirmatory testing done through the (b)(6) resulted in negative for hsv 1 and 2.The psychological effects of having this false positive diagnosis, not only by the labtests but also by my pcp having no knowledge of how to confirm testing or offer coping mechanisms, was a heavy burden to bear.If current hsv tests have so much room for error, it should be considered that the tests shouldn't be done in favor of the (b)(6) definitive test, or at the very least a more serious effort should be put into educating providers and the general public about hsv testing options and what to expect.Navigating this all on my own was a lot, and i was lucky i got to connect with the experts in this area of study.Due to the nature of hsv transmission also occurring most during asymptomatic shedding, more effort should be put into shedding diagnostics for patients who have hsv, and more funding put into cure for hsv which dr.(b)(6) and her team are researching.Current research is also conflicting as to how effective antivirals are at preventing transmission; it only suggests their effectiveness at reducing painful lesions.There needs to be a better approach to hsv besides just "you have it, you're "profanity" and this is your life now." condoms and protective barriers can only go so far.I have never had cold sores or genital lesions in my life whatsoever.Reference report: mw5154370.

• Brand Name: HSV IGG 2
• Type of Device: ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 19205031
• MDR Text Key: 341431487
• Report Number: MW5154371
• Device Sequence Number: 1
• Product Code: MYF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2024
• Patient Sequence Number: 1
• Treatment: IBUPROFEN.; LEXAPRO 15MG.; MIRENA INTRAUTERINE DEVICE.; TYLENOL.
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 43 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian, Native Hawaiian Or Other Pacific Islander