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

Lot Number COV2010009

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Date 04/25/2022

Event Type  malfunction  

Manufacturer Narrative

Batch records for final product manufacturing and qc record for (b)(4) 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 from (b)(4) can meet the qc criteria.We have not found the complaint issue from the retained cassettes.The complaint is not verified.

Event Description

Invalid result(s).We got a call from a customer that is having an issue with a flowflex covid 19 antigen test kit.The customer has just purchased the test kit, so this is an out of box issue.Customer called in because the test cassette has no c-line or t-line.Customer confirmed that he had applied 4 drops of buffer solution to the s-well, and waited until 15-30 mins.No control line or test line appeared.Customer is not able to send a picture of the cassette.I advised the customer that i need to forward this information to the appropriate department for review.Customer will wait for the follow up response from acon labs.

• 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: 16400471
• MDR Text Key: 309984234
• Report Number: 2531491-2023-00357
• 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: 01/04/2022
• Device Lot Number: COV2010009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2022
• 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