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

Lot Number COV2030023

Patient Problem Insufficient Information (4580)

Event Date 01/03/2024

Event Type  malfunction  

Event Description

Purchased 10 flowflex tests with 3/2/24 extended expiration and 8 of 10 control window either failed or was too faint to rely on these.Tests are too old and should be pulled.Selling bad tests at (b)(6) dollars each is horrible.This is not a user problem with the test.I have done 2 tests per week for over a year due to caregiving.These tests are too old and they are ripping people off with the extended expiration.Reference reports: mw5149823, mw5149824, mw5149826, mw5149827, mw5149828, mw5149829, mw5149830.

• Brand Name: FLOWFLEX COVID 19 ANTIGEN HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 18454016
• MDR Text Key: 332323218
• Report Number: MW5149825
• 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: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/02/2024
• Device Lot Number: COV2030023
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Race: White