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

Lot Number COV2020447

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Date 05/19/2022

Event Type  malfunction  

Manufacturer Narrative

Invalid lot number was provided, investigation unable to be perform.

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 her test cassette has no c-line or t-line.Customer confirmed that she performed the test correctly, and 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 does not have an email address she can provide.I advised the customer that i need to forward this information to the appropriate department for review.Customer will wait for the replacement kit.No email available.

• 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: 16397173
• MDR Text Key: 309773958
• Report Number: 2531491-2023-00366
• 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: 02/16/2023
• Device Lot Number: COV2020447
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2022
• 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