MAUDE Adverse Event Report: INNOVA MEDICAL GROUP, INC. COVID-19 SELF-TEST (RAPID ANTIGEN TEST); REAGENT, CORONAVIRUS SEROLOGICAL

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

Patient Problems Fever (1858); Headache (1880); Sore Throat (2396); Cough (4457)

Event Date 06/11/2021

Event Type  malfunction  

Event Description

Hi, i am a (b)(6) citizen with concerns about lateral flow testing used in our country for asymptomatic covid testing, and wanted to share my reservations as the fda have recently published about this.I am a simple college student and we were told to keep ourselves safe by taking two antigen tests per week, at the university; these aren't performed by a medical professional, you have to do it yourself.My housemate had a sore throat, which isn't indicated as a main covid symptom by the nhs, and noticed her manager had as well.They decided to have an asymptomatic test just to check.My housemate was tested twice using the innova lateral flow test (at three days interval) and received a negative result both times, which led her to socialize with the rest of us.Two days after the last test, after everyone at her workplace had started catching the virus, she took a pcr test and it came back positive.Interestingly, she had actually left for another city after taking the second lateral flow test, which is why i must have caught it before her second lateral flow test, meaning she was already infectious at that time.Various people at her workplace have tested positive, and i am waiting for my result, but experiencing moderate symptoms of the virus: the first two days, i simply had a sore throat which wouldn't go and a few headaches; this was very misleading as it seemed like a very minor ailment.Yesterday, i noticed one of my housemates sweating heavily, as if from a fever, and i started to develop a cough, with a bit of fever as well, thus i am fairly convinced that my pcr test will return positive (i have also taken a lateral flow test, negative).Although i fully understand how this test isn't designed to detect a person with a low viral load or at the beginning of the virus, we need your help.Students (18-25) are not yet eligible for the covid vaccine in (b)(6), and are being "protected" via these tests which do not work most of the time.The delta variant is spreading more rapidly than ever, and vaccinated people are still not fully protected; on top of this, it seems to be detected with much less accuracy by lateral flow tests.Therefore, the distribution of said tests to (b)(6) population is actually likely to cause a terrible wave of covid within the next two weeks.The nhs is yet to investigate and reports published regarding test accuracy seem to be inaccurate.Please, the fda seems to be the only organization interested in investigating these matters, please look into this more, please put pressure on (b)(6) to investigate, get this information out.No one in my household (8 people) had heard of the fda article regarding these tests, so i am assuming most people do not know about it.Fda safety report id# (b)(4).

• Brand Name: COVID-19 SELF-TEST (RAPID ANTIGEN TEST)
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): INNOVA MEDICAL GROUP, INC. ; 785 challenger st. ; brea CA 92821
• MDR Report Key: 12008003
• MDR Text Key: 256746182
• Report Number: MW5101894
• Device Sequence Number: 2
• Product Code: QKO
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/11/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20 YR