MAUDE Adverse Event Report: COVID-19 ANTIBODY COMPREHENSIVE TEST; REAGENT, CORONAVIRUS SEROLOGICAL

Device Problems Product Quality Problem (1506); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2022

Event Type  malfunction  

Event Description

We have three members in our household (one of whom is not biologically related) who could not obtain enough blood to provide a sample sufficient for testing despite explicitly following all directions.We called the company (4u health); the co-founder, "(b)(6)," instructed us to run our hands under warm water and assured us that this remedy worked "99% of the time." all three of us made a subsequent attempt following this additional instruction and still could not obtain a sufficient sample.We have left multiple messages for the company since then and have not received a call back.We believe this product is not user-friendly to the average person and should not be marketed to the general public.

Event Description

Additional information received on 01/11/2022 for report mw5114159 to update procode to qko.

• Brand Name: COVID-19 ANTIBODY COMPREHENSIVE TEST
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• MDR Report Key: 16103040
• MDR Text Key: 306801375
• Report Number: MW5114159
• Device Sequence Number: 1
• Product Code: QKO
• 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,Followup
• Report Date: 12/31/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/19/2023
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALFUZOSIN; AMOXICILLIN; ASPIRIN ; ATORVASTATIN ; CENTRUM SILVER; PLAVIX
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White