MAUDE Adverse Event Report: VIOME VIOME LIFESCIENCES, INC. VIOME MICROBIOME TEST; GENERAL PURPOSE REAGENT

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

Event Date 02/14/2024

Event Type  malfunction  

Event Description

I purchased an at home microbiome test from viome.They said that they can't give me my results, but instead said that i was 40% good bacteria and offered to sell me supplements.I have a phd in molecular pharmacology and structural biology so what kind of a scam is this? thanks (b)(6).

• Brand Name: VIOME MICROBIOME TEST
• Type of Device: GENERAL PURPOSE REAGENT
• Manufacturer (Section D): VIOME VIOME LIFESCIENCES, INC.; 205 108th ave. ne; suite 150; bellevue WA 98004
• MDR Report Key: 18858160
• MDR Text Key: 337457077
• Report Number: MW5152462
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/04/2024

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: 03/06/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White