MAUDE Adverse Event Report: ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number	L031-118B5
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
I used a flowflex covid-19 at-home antigen test and received suspicious results: on (b)(6) 2022 at 9am did the test per package directions, except also swabbed throat per guidance from research, and received a weak positive result.3 hours later i performed a supervised naat test at university of washington (no throat swab, per supervised procedure), received a negative test result.On (b)(6) 2022 at 9am, did another rapid antigen test from another manufacturer (same procedure deviation above), received a negative result.On (b)(6) 2022 at 9am, did another flowflex rapid antigen test (same lot, same procedure) and received again a weak positive result.On (b)(6) 2022 i had nasal congestion.Nasal congestion resolved between the naat test on (b)(6) 2022 and rat test on (b)(6) 2022.No covid-specific symptoms appeared as they did during my previous covid infection (cough, lung capacity reduction, difficulty exercising).Fda safety report id# (b)(4).

• Brand Name: FLOWFLEX COVID-19 ANTIGEN HOME TEST
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 14052173
• Report Number: MW5108822
• Device Sequence Number: 16802644
• Product Code: QKP
• UDI-Device Identifier: 00682607660261
• UDI-Public: (01)00682607660261
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 04/06/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/09/2023
• Device Model Number: L031-118B5
• Device Catalogue Number: 660261
• Device Lot Number: COV2010020
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2022
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White