METABOLISM+ TEST
Received Mar 31, 2020 · Event occurred Jun 21, 2019
Report MW5094002 · MDR key 9910473
Device
Generic name
Genetic Variant Detection And Health Risk Assessment System
Manufacturer
UnkProduct problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
34 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
I PURCHASED THE FOOD SENSITIVITY TEST+ AND METABOLISM TEST+ FROM EVERLYWELL. WHILE I REALIZE THE LINK WILL BE REMOVED FROM THE MAUDE REPORT, HERE IS THE ADDITIONAL INFORMATION (INCLUDING THE PDF REPORTS) FOR THE FDA: (B)(4). ESSENTIALLY, I ENCOUNTERED THE FOLLOWING ISSUES: I THINK THAT THERE WAS AT LEAST ONE TECHNICAL ISSUE WITH THE BLOOD TESTS: I HAVE TSH TESTS FROM BLOOD DRAWS, AND THE EVERLYWELL RESULT WAS A BIT HIGHER THAN THE BLOOD DRAWS FROM QUEST (EVEN THOUGH I THINK IT WAS STILL WITHIN THE NORMAL LEVELS). I WAS GUESSING IT WAS POSSIBLE THIS WAS DUE TO THE SMALLER AMOUNT OF BLOOD COLLECTED, BUT I DON'T KNOW FOR CERTAIN; I HAD BIOLOGICAL CONCERNS ABOUT THE SNP INTERPRETATIONS FROM DNA GENOTYPING THAT WERE BEING PROVIDED, BUT I DON'T BELIEVE I SAW ANYTHING THAT WAS TECHNICALLY WRONG WITH THOSE (AND I THINK THOSE WERE PROVIDED FROM HELIX, WHOSE PARTNERSHIP HAS BEEN DISCONTINUED); EVERY WELL (+ HELIX). FDA SAFETY REPORT ID # (B)(4).