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 Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 05/05/2022

Event Type  Injury  

Event Description

Patient had a hsv 2 positive test on the diasorin hsv 1 and 2 igg test, (index value = 3.85), followed up with a western blot which was negative for hsv 2.Date given is the western blot confirmatory test.

• 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: 16809695
• MDR Text Key: 314014155
• Report Number: MW5117009
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White