inforMED
MalfunctionPTA

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

Unk

Product 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).