MAUDE Adverse Event Report: MY LAB BOX HSV 2 TEST KIT; HERPES SIMPLEX VIRUS NUCLEIC ACID AMPLIFICATION ASSAY

Patient Problems Depression (2361); Sleep Dysfunction (2517); Weight Changes (2607); Suicidal Ideation (4429)

Event Date 04/04/2024

Event Type  malfunction  

Event Description

I ordered an std test kit from my lab box which includes an hsv 2 test.I got positive with no index number.It took me 4 days for them to email me the index number.I think they hid it and are banking on customers' ignorance.Several people on trust pilot have had the same experience.Their website says once you test positive for hsv 2 there is no need to retest.After reading the fda and cdc websites and going on reddit deep dives i learned about false positives.The assigned physician was eager to prescribe me medication and told me the test was 90% accurate.Not true.I was depressed and suicidal for 10 days until i got a follow-up test at (b)(6) that confirmed i did not have hsv2.I do not believe my lab box should be selling this test as i have recently learned that it is not a part of the regular std panel because of the psychological damage a false positive can cause.They are clearly in it for the money and not for the client's well-being.I lost (b)(6) dollars, sleep, and weight from not eating due to this misinformation and carelessness.I do not want this to happen to anyone else.Please make them remove this test from their website asap.

• Brand Name: MY LAB BOX HSV 2 TEST KIT
• Type of Device: HERPES SIMPLEX VIRUS NUCLEIC ACID AMPLIFICATION ASSAY
• MDR Report Key: 19142185
• MDR Text Key: 340573817
• Report Number: MW5153978
• Device Sequence Number: 1
• Product Code: OQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/16/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Patient Sequence Number: 1
• Treatment: UBER BOX
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: Black Or African American