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

Lot Number COV2010017

Device Problem Non Reproducible Results (4029)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2023

Event Type  malfunction  

Event Description

Invalid result (s).Customer has 4 ff kits.The first one she tested showed no lines after the sample was applied.She confirmed she did perform the test correctly.

Manufacturer Narrative

Batch records, final product manufactured, and qc records were reviewed for lot cov2010017.No abnormal issue was found in the manufacturing process, technical testing and quality control inspection, the manufacturing process complied with the dmr.Retention samples were checked and have met the qc criteria.The issue was not found.This 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

Invalid result (s).Customer has 4 ff kits.The first one she tested showed no lines after the sample was applied.She confirmed she did perform the test correctly.

• 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: 16401083
• MDR Text Key: 309888073
• Report Number: 2531491-2023-00533
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

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: COV2010017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 03/30/2023
• 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