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

Lot Number COV2010002

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Date 07/14/2022

Event Type  malfunction  

Manufacturer Narrative

Batch records for final product manufacturing and qc records for cov2010002 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 cov2010002 met the qc criteria.The complaint issue was not found with the retention samples.The complaint is not verified.Similar issues will be tracked and trended.

Event Description

Invalid result (s).Customer has a 5 pack of the flowflex and she had 3 tests that didn't have any lines.2 of the test worked as expected.She confirmed that she followed the instructions properly but no c or t line appeared on 3 out of 5.Customer feels the tests were defective.

• 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: 16397576
• MDR Text Key: 309772752
• Report Number: 2531491-2023-00394
• 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

• 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: COV2010002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 02/17/2023
• 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