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

Lot Number COV2020045

Device Problem False Negative Result (1225)

Patient Problem Viral Infection (2248)

Event Date 09/24/2022

Event Type  malfunction  

Event Description

I received acon flowflex covid tests through insurance at cvs.I recently had a positive test through 2 other brands and am very symptomatic.I wanted to make sure they worked after reading the 1 star reviews and the test is showing negative.I tried 2 more and still negative.You need to look at these reviews.They're billing insurance for bad tests.If the t bar is positive, it's so faint you can't see it.Lot cov2020045, exp 2/7/2023.Fda safety report id# (b)(4).

• 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: 15498624
• MDR Text Key: 300798038
• Report Number: MW5112279
• Device Sequence Number: 3
• 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: 09/24/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: COV2020045
• Patient Sequence Number: 1
• Treatment: TYLENOL FOR FEVER
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White