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

Lot Number	COV3090005
Health Effect - Clinical Code	Viral Infection (2248)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Tested using a covid-19 antigen test from acon laboratories, inc., san diego, ca 92121.The test gave a false negative as compared to a second antigen test.I am strongly positive by binax now and pcr test.

• 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: 18364543
• Report Number: MW5149393
• Device Sequence Number: 20727965
• Product Code: QKP
• UDI-Device Identifier: 00682607660261
• UDI-Public: (01)00682607660261
• Combination Product (Y/N): N
• 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): 12/15/2023

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: 08/31/2025
• Device Lot Number: COV3090005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2023
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian