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

Lot Number COV2010017

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Date 05/11/2022

Event Type  malfunction  

Manufacturer Narrative

Batch records for final product manufacturing and qc records for cov2010017 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 cov2010017 met the qc criteria.The complaint issue was not found with the retained cassettes.The root cause is undertermined.Similar issues will be tracked and trended.

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, because he had thrown it away.I advised the customer that i need to forward this information to the appropriate department for review.

• 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: 16397623
• MDR Text Key: 309774105
• Report Number: 2531491-2023-00361
• 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: 01/09/2023
• Device Lot Number: COV2010017
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2022
• 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