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

Device Problem False Positive Result (1227)

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

Event Date 05/09/2022

Event Type  Injury  

Event Description

Patient had two hsv 2 positive tests on the diasorin hsv 1 and 2 igg test, (index values = 1.73 and 2.01), followed up with a western blot which was negative for hsv 2.Date given is the western blot confirmatory test.Reference report: mw5116957.

• Brand Name: DIASORIN LIASON XL HSV 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: 16807083
• MDR Text Key: 314073490
• Report Number: MW5116956
• 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: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White