MAUDE Adverse Event Report: VIOME LIFE SCIENCES GUT INTELLIGENCE TEST; CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Event Description

I tried to submit an fda medwatch report before, but i am not sure if that went through (i have not received the typical confirmation for including in the maude database yet).I have also collected additional data since that earlier submission.Either way, these are the essentially the concerns that i currently have: several specific supplement recommendations are being made by (b)(6).Those recommendations vary in dosage (as well as sometimes specifying different supplements) for the 2 (b)(6) samples collected and submitted at the same time.Again, you can see noticeable differences in 2 collections for the same sample, as well as 3 other subsequent collections: (b)(6).I know that i have gotten a headache from taking a high dosage of zinc (from another company, for which i submitted a separate medwatch report).I was hesitant to test any of the supplement recommendations, but i will submit separate medwatch reports if i do and i encounter adverse reactions.Additionally, i think that the number of recommendations seems high.So, i hope somebody with more of a medical background can review this table and guess if this has a non-trivial chance of causing harm (before tested by customers like myself).In general, there are also pathway scores for the same stool sample were noticeably different.You can see the details for those samples / analysis here (including a link to github, with possibly complementary analysis):(b)(6); there are also food recommendations.I have listed the "foods to avoid" below.Again, please notice the variation in the predictions, and a number of them go against my own experience: (b)(6) so, i have not taken any actions based upon these reports (or between collection intervals).If the formatting submitted through medwatch is hard to read, then a formatted version of this submission is available here: (b)(6).Fda safety report id# (b)(4).

• Brand Name: GUT INTELLIGENCE TEST
• Type of Device: CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE
• Manufacturer (Section D): VIOME LIFE SCIENCES
• MDR Report Key: 13060498
• MDR Text Key: 282900916
• Report Number: MW5106218
• Device Sequence Number: 1
• Product Code: NNK
• 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: 12/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CITALOPRAM ; INDOMETHACIN ; RESTASIS
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White