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

Lot Number COV2020095

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2023

Event Type  malfunction  

Event Description

Invalid result (s).We got a call from a customer that is having an issue with the flowflex covid 19 antigen test kit.This is an out of box issue.When the customer performed the covid test, nothing appeared in the test window.The customer did say the s-window had a pinkish color, 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 cannot send a picture of the test cassette in question, she does not have the ability.I advised the customer that i need to forward this information and she will get an email back from acon labs regarding this issue.

Event Description

Invalid result (s).We got a call from a customer that is having an issue with the flowflex covid 19 antigen test kit.This is an out of box issue.When the customer performed the covid test, nothing appeared in the test window.The customer did say the s-window had a pinkish color, 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 cannot send a picture of the test cassette in question, she does not have the ability.I advised the customer that i need to forward this information and she will get an email back from acon labs regarding this issue.

Manufacturer Narrative

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 cov2020095 met the qc criteria.The complaint issue was not reproduced with the retention samples.The root cause is undetermined.Similar issues will be tracked and trended.In this follow-up report, the following information has been updated from the initial report upon completion of the internal investigation.The following fields are updated: b4, "date of this report" - date of follow-up report.G6, "type of report" - follow-up #1.H2, "if follow-up, what type?" - updated to "additional information" and "device evaluation" h6 "adverse event problem" - event problem and evaluation codes such as "investigation.Findings" and "investigation: conclusions" are added per investigation.H10 "additional narrative/data" - added manufacturer's narrative.

• 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: 16397515
• MDR Text Key: 309773752
• Report Number: 2531491-2023-00483
• 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: 03/15/2023

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 Lot Number: COV2020095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2023
• 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