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

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

Event Date 09/17/2023

Event Type  malfunction  

Event Description

I took a hsv2 (herpes simplex virus) test which uses igg (immunoglobulin g) and received an initial low positive result.I then took a confirmation test (inhibition assay) and was normal (not detected).Meaning, my first result was a false positive.9/17 test from labcorp 9/26 test from quest.Resulted on 10/10 (took 14 days to result).

• Brand Name: HSV 2 IGG TEST
• Type of Device: ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18487211
• MDR Text Key: 332783667
• Report Number: MW5150106
• Device Sequence Number: 1
• 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: 01/05/2024

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: 01/09/2024
• Patient Sequence Number: 1
• Treatment: CLARITIN PRN (PRO RE NETA / AS NEEDED) ALLERGIES.
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White