MAUDE Adverse Event Report: DIASORIN, INC. DIASORIN LIASON XL HSV 1 AND 2 TYPE SPECIFIC ANTIBODY TEST; ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2

Device Problem Device Remains Activated (1525)

Patient Problem Insufficient Information (4580)

Event Date 05/10/2022

Event Type  Injury  

Event Description

Patient had two hsv 1 positive tests (index values = 1.27 and 1.14) and two hsv 2 positive tests (index values = 1.12 and 1.01) on the diasorin hsv 1 and 2 igg test, followed up with a western blot which was negative for hsv 1 and 2.Date given is the western blot confirmatory test.Reference reports mw5116160, mw5116161, mw5116163.Relevant tests/laboratory data: test 1; test date: 10-may-2022; test name: herpes western blot (b)(6).Test result: negative.

• Brand Name: DIASORIN LIASON XL HSV 1 AND 2 TYPE SPECIFIC ANTIBODY TEST
• Type of Device: ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2
• Manufacturer (Section D): DIASORIN, INC.
• MDR Report Key: 16656464
• MDR Text Key: 312647951
• Report Number: MW5116162
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White