MAUDE Adverse Event Report: UNKNOWN HSV 1 IGG,TYPE SPECIFIC AB; ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-1

Model Number IGG

Patient Problem Anxiety (2328)

Event Date 03/24/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024, blood sample was taken for hsv 1/2 igg,type specific ab testing.Results were received (b)(6) 2024 and indicated an equivocal result for hsv-1.On (b)(6) 2024, blood sample was taken for (b)(6) hsv western blot testing.Results were received (b)(6) 2024 and indicated a negative result for hsv-1.I am concerned about the reliability of igg testing as the mental reaction of receiving an equivocal result was quite anguishing.I would like to escalate viability of western blot testing as a more reliable method.(b)(6).Reference report: mw5153421.

• Brand Name: HSV 1 IGG,TYPE SPECIFIC AB
• Type of Device: ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-1
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18990008
• MDR Text Key: 338944403
• Report Number: MW5153286
• Device Sequence Number: 1
• Product Code: MXJ
• 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: 03/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: IGG
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian