MalfunctionPCA
VITAGENE DNA TEST
Received Jan 6, 2020 · Event occurred Jul 11, 2019
Report MW5092056 · MDR key 9558943
Device
Generic name
Dna Genetic Analyzer
Manufacturer
VitageneProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
34 YR
- Patient Problem/Medical Problem
- Patient Problem/Medical Problem
Narrative
Description of Event or Problem
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).