MAUDE Adverse Event Report: LABCORP HSV 2 IGG 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 08/01/2021

Event Type  malfunction  

Event Description

False positive (b)(6) antibody result.Igg test from labcorp was (b)(6) at 3.14, western blot confirmatory test was (b)(6) for (b)(6).Supplemental test from labcorp (b)(6), western blot (b)(6).Fda safety report id# (b)(4).

• Brand Name: LABCORP HSV 2 IGG TEST
• Type of Device: ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2
• MDR Report Key: 12392337
• MDR Text Key: 269422238
• Report Number: MW5103614
• Device Sequence Number: 1
• Product Code: MYF
• 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: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR