MAUDE Adverse Event Report: VITAGENE VITAGENE DNA TEST; DNA GENETIC ANALYZER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/11/2019

Event Type  malfunction  

Event Description

I have never reported to fda medwatch before.I actually have multiple genomics results that the fda may be interested in here: (b)(6) however, this is specifically about vitagene, where i was concerned about the number of supplements recommended (one of which i did have a mild adverse reaction to l-theanine, even with the assumption that i should test 1 new supplement at a time): (b)(6).Fda safety report id # (b)(4).

• Brand Name: VITAGENE DNA TEST
• Type of Device: DNA GENETIC ANALYZER
• Manufacturer (Section D): VITAGENE
• MDR Report Key: 9558943
• MDR Text Key: 174500474
• Report Number: MW5092056
• Device Sequence Number: 1
• Product Code: PCA
• 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: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 79