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

Lot Number COV2010001

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2022

Event Type  malfunction  

Event Description

Invalid result (s).Test cassette did not produce a result.

Manufacturer Narrative

Batch records for final product manufacturing and qc records for cov2010001 were reviewed and no abnormal issue was found in the manufacturing process, technical testing and quality control inspection, and the manufacturing process.The test results of retention samples of cov2010001 met the qc criteria.The complaint issue was not found in the retained cassettes.The root cause is undertermined.Similar issues will be tracked and trended.

• 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: 16397505
• MDR Text Key: 309772639
• Report Number: 2531491-2023-00393
• 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
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/03/2023
• Device Lot Number: COV2010001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2022
• 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