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

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

Event Date 12/27/2023

Event Type  malfunction  

Event Description

(b)(6) did a 10-test std panel on (b)(6) 2023 that included the hsv-2 igg, type specific ab test that yielded a positive result (2.59h).I ordered their hsv-2 igg inhibition, ia test on (b)(6) 2023 and the igg screening assay yielded a negative result (< 0.90).I'm asymptomatic of hsv-2.As part of the hsv-2 igg inhibition, ia they redo the hsv-2 igg screening assay and that returned a < 0.90 (thus inhibition could not be determined) only 3 days after the hsv-2 igg, type specific ab.

• Brand Name: BLOOD TEST: HSV-2 IGG, TYPE SPECIFIC AB
• Type of Device: ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2
• Manufacturer (Section D): QUEST INTL., INC.
• MDR Report Key: 18486317
• MDR Text Key: 332802378
• Report Number: MW5150077
• Device Sequence Number: 1
• Product Code: LGC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/05/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White