MAUDE Adverse Event Report: QUEST INTL., INC. QUEST IGG HSV2 TEST; ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2

Patient Problems Viral Infection (2248); Needle Stick/Puncture (2462)

Event Date 03/20/2024

Event Type  malfunction  

Event Description

I got a false positive igg hsv2 test.My doctor was unfamiliar with the proper tests and when this test is indicated per cdc protocols, and had me get it despite me telling them i tested falsely positive once before and do not fit the demographic.I asked to get the confirmation/inhibition test right off the bat and it wasn't ordered correctly meaning i had to take an additional blood test and get poked again with a needle unnecessarily, not to mention the embarrassment, stigma and uncertainty that comes with this disease.Completely avoidable use of medical resources.Each time i get a false positive, i happen to be recovering from a cold or about to get one.

• Brand Name: QUEST IGG HSV2 TEST
• Type of Device: ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2
• Manufacturer (Section D): QUEST INTL., INC.
• MDR Report Key: 19212685
• MDR Text Key: 341539491
• Report Number: MW5154429
• 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: 04/29/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White