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

Model Number	(17)221201
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Flowflex rapid covid test appears to have provided multiple false positives.Tested my son (age (b)(6), made sure to follow the directions carefully and get a good sample) multiple times.Used the same brand on myself, husband, and other son and got negatives.Followed with carestart brand antigen test (negative), (b)(6) state project beacon pcr test (negative), (b)(6) vanguard in (b)(6) rapid test (negative), and a (b)(6)vanguard in (b)(6), pcr test (negative).Ref l031-118b5, lot cov1120041, (expires 2022-12-01) made in (b)(6); l031319-01, numbers next to qr code: (01)00682607660261 (17)221201 (10)cov1120041, bar code: 682607660261.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: 14257478
• Report Number: MW5109441
• Device Sequence Number: 17427581
• Product Code: QKP
• UDI-Device Identifier: 00682607660261
• UDI-Public: (01)00682607660261
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 04/28/2022

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 Expiration Date: 12/01/2022
• Device Model Number: (17)221201
• Device Catalogue Number: 682607660261
• Device Lot Number: (10)COV1120041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BENADRYL
• Patient Age: 4.5 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White