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

(b)(6) igg antibody test from (b)(6) confirmatory test (b)(6).Cdc recommends this test as a confirmatory test for (b)(6) antibody testing.The igg test was done at (b)(6).The confirmatory test was done at (b)(6).The (b)(6) was done at (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: 12392325
• MDR Text Key: 270255838
• Report Number: MW5103613
• 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

• Is this an Adverse Event Report?: No
• 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: 08/30/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25 YR