MAUDE Adverse Event Report: ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST; ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP

Lot Number COV2010023

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Malaise (2359); Cough (4457)

Event Date 11/15/2022

Event Type  malfunction  

Event Description

Inconsistent result(s).Rebound covid-19 test after anti-viral, molnupiravir.Regular course of tx, 2 negative tests.Next day tested positive again.Only symptoms productive cough and mild malaise.Medwatch mdr (mw5113344).

Manufacturer Narrative

Final product manufacture and qc record for (b)(4) were reviewed.No abnormal issue was found in manufacturing process, technical testing and quality control inspection, and the manufacturing process is complied with dmr.Please see the (b)(4) attachment for reference.He test results of retention samples from (b)(4) can meet the qc criteria.We have not found the complaint issue from the retained cassettes.The complaint is not verified.In this follow-up report, the following information has been updated from the initial report upon completion of the internal investigation.

Event Description

Inconsistent result(s).Rebound covid-19 test after anti-viral, molnupiravir.Regular course of tx, 2 negative tests.Next day tested positive again.Only symptoms productive cough and mild malaise.Medwatch mdr (mw5113344).

• Brand Name: FLOWFLEX COVID-19 ANTIGEN HOME TEST
• Type of Device: ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP
• Manufacturer (Section D): ACON LABORATORIES, INC.; 5850 oberlin drive #340; san diego CA 92121
• Manufacturer (Section G): ACON LABORATORIES, INC.; 5850 oberlin drive #340; san diego CA 92121
• Manufacturer Contact: qiyi xie ; 5850 oberlin drive #340; san diego, CA 92121 ; 8588758011
• MDR Report Key: 16330062
• MDR Text Key: 309605867
• Report Number: 2531491-2023-00106
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• PMA/PMN Number: EUA210494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

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 Operator: Lay User/Patient
• Device Lot Number: COV2010023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1