MAUDE Adverse Event Report: METABOLISM+ TEST; GENETIC VARIANT DETECTION AND HEALTH RISK ASSESSMENT SYSTEM

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2019

Event Type  malfunction  

Event Description

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).

• Brand Name: METABOLISM+ TEST
• Type of Device: GENETIC VARIANT DETECTION AND HEALTH RISK ASSESSMENT SYSTEM
• MDR Report Key: 9910473
• MDR Text Key: 186182008
• Report Number: MW5094002
• Device Sequence Number: 1
• Product Code: PTA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 79