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

Lot Number COV2020152

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Date 01/23/2023

Event Type  malfunction  

Event Description

Invalid result (s).Called in because he purchased a flowflex kit and no results displayed.No c or t line appeared.He followed the directions exactly and dispensed the 4 drops into the s well.The desiccant pack was inside the test cassette pouch.

Event Description

Invalid result (s).Called in because he purchased a flowflex kit and no results displayed.No c or t line appeared.He followed the directions exactly and dispensed the 4 drops into the s well.The desiccant pack was inside the test cassette pouch.

Manufacturer Narrative

Batch records for final product manufacturing and qc record for cov2020152 and no abnormal issue was found in the manufacturing process, technical testing and quality control inspection, and the manufacturing process.Retention samples of cov202052 were tested and met the qc criterion and the issue was not found from the retained test cassettes.The complaint is not verified.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: 16392009
• MDR Text Key: 309767487
• Report Number: 2531491-2023-00488
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: COV2020152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2023
• 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