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

Lot Number COV1125010

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2022

Event Type  malfunction  

Manufacturer Narrative

No abnormal issue was found in the manufacturing process, technical testing and quality control inspection, and the manufacturing process was complied with the dmr.

Event Description

Invalid result (s).We got an email from answer net, regarding a customer that is having an issue with a flowflex covid 19 antigen test kit.I called the customer back and confirmed the complaint details.The customer has just purchased the test kit, so this is an out of box issue.When the customer performed the test correctly, the result shows a faint t-line, and no c-line (control line).Customer performed the test correctly with 4 drops of the buffer solution.I had the customer send a picture of the test cassette.I advised the customer that she will be receiving an email back from acon labs regarding this matter.

• 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: 16387624
• MDR Text Key: 309764129
• Report Number: 2531491-2023-00320
• 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: 02/16/2023

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: 12/12/2022
• Device Lot Number: COV1125010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 02/16/2023
• 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