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

Lot Number L031332-01

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The flow flex covid-19 antigen home test did not show a control line.When using a second test from the same lot, the control line appeared but was very faint at 15 minutes.There is a problem with these tests and could cause false negative results.Test was faulty, had no control line.

• Brand Name: FLOWFLEX HOME COVID-19 ANTIGEN TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 16025656
• MDR Text Key: 305994174
• Report Number: MW5113884
• Device Sequence Number: 1
• Product Code: QKP
• 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
• Report Date: 12/19/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/03/2023
• Device Lot Number: L031332-01
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White