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

Lot Number	COV2020191
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
I had covid symptoms, as did my whole family.Previous tests were negative but we tested again, because we were on days 3 and 4 so approaching the time limit for paxlovid.I got a faint positive flowflex test (in white packaging), so i tested again.I got a faint positive again.Everyone else in my family tested negative despite my kid being sicker than me.Because my sister had two false positives with the same kind of test two weeks ago, i was suspicious.I used a binax test, which came up negative.I also scheduled a test to treat appointment to confirm, and get paxlovid if i was positive because i'm high risk.The healthcare provider did a pcr test, which was negative.It appears both flowflex tests were false positives.Two faint positives, that were false positives.Model/catalog/udi number: unsure, see label picture.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: 15192118
• Report Number: MW5111335
• Device Sequence Number: 6456111
• Product Code: QKP
• UDI-Device Identifier: 00682607660261
• UDI-Public: 0100682607660261
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 08/07/2022
• 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: 02/27/2023
• Device Lot Number: COV2020191
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BUPROPION ; METFORMIN ; PRENATAL VITAMINS; SERTRALINE; VITAMIN B12
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White