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

Lot Number COV2010030

Device Problem Unable to Obtain Readings (1516)

Patient Problem Insufficient Information (4580)

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

The current complaint is pending investigation from our contract manufacturer, and we will provide follow up mdr upon investigation completion such as review of batch records or testing of retention samples.Any additional information received by acon may be provided to fda in a follow up mdr.

Event Description

Invalid result (s).The customer just purchased the 12pack of kits from his local pharmacy, so this is an out of box issue.When the customer performed the first 4 tests correctly, nothing appeared in the result window.The test window was blank, nothing next to the c-line or t-line.Customer performed the test correctly with 4 drops of the buffer solution and waited the 15 minutes.The customer sent a picture of the 1 of test cassettes, all the cassettes are the same, no result in the result window, nothing visible.

Event Description

Invalid result (s).The customer just purchased the 12pack of kits from his local pharmacy, so this is an out of box issue.When the customer performed the first 4 tests correctly, nothing appeared in the result window.The test window was blank, nothing next to the c-line or t-line.Customer performed the test correctly with 4 drops of the buffer solution and waited the 15 minutes.The customer sent a picture of the 1 of test cassettes, all the cassettes are the same, no result in the result window, nothing visible.

Manufacturer Narrative

Batch records for final product manufacture and qc record for cov2010030 were reviewed and no abnormal issue was found in manufacturing process, technical testing and quality control inspection, and the manufacturing process is complied with dmr.Retention samples were tested and met the qc criteria.The complaint issue was not found in 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.

• 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
• MDR Report Key: 18471876
• MDR Text Key: 332507795
• Report Number: 2531491-2024-00005
• 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: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: COV2010030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2024
• 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