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

Lot Number COV3090012

Device Problem Unable to Obtain Readings (1516)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2024

Event Type  malfunction  

Event Description

Invalid results.The customer performed the test procedure correctly and neither the control (c) nor the test (t) lines appeared on the test cassette.The customer stated that the test kits were purchased from cvs.

Manufacturer Narrative

The current complaint is pending investigation from our contract manufacturer, and we will provide follow up mdr upon investigation completion such as review of batch records or testing of retention samples.Any additional information received by acon may be provided to fda in a follow up mdr.

Event Description

Invalid result (s).Invalid results.The customer performed the test procedure correctly and neither the control (c) nor the test (t) lines appeared on the test cassette.The customer stated that the test kits were purchased from cvs.

Manufacturer Narrative

Final product manufacture and qc record for (b)(6).No abnormal issue was found in manufacturing process, technical testing and quality control inspection, and the manufacturing process is complied with dmr.The test results of retention samples from (b)(6)can meet the qc criteria.We have not found the complaint issue from the retained 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
• MDR Report Key: 18822949
• MDR Text Key: 336860326
• Report Number: 2531491-2024-00033
• 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: 03/01/2024

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 Lot Number: COV3090012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• 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