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

Lot Number COV2020172

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Insufficient Information (4580)

Event Date 04/14/2023

Event Type  malfunction  

Manufacturer Narrative

No abnormal issue was found in the manufacturing process, technical testing and quality control inspection, and the manufacturing process was complied with the dmr.We checked retention samples of this batch, and no related issue was found.Due to limited information provided by the customer and no figures were available, the root cause isn't identified, this case is determined as an isolated issue, and we will trace similar issues.

Event Description

Invalid result (s).I was trying to use a covid test and when i opened the buffer vial there was a worm in it.An actualworm.Mw5116548.

Event Description

Invalid result (s).I was trying to use a covid test and when i opened the buffer vial there was a worm in it.An actual worm.Mw5116548.

Manufacturer Narrative

Bacth records for (b)(6) were reviewed and no abnormal issue was found in the manufacturing process, technical testing and quality control inspection, and the manufacturing process was complied with the dmr.The batches of buffer used in this batch product were as follow: 220218-c3867-308(220209009), 220221-c3867-442(220214003), 220222-c3867-458(220215006); 220224-c3867-419(220215003), 220224-c3867-420(220215003), 220224-c3867-421(220215003); 220225-c3867-422(220209003), 220225-c3867-425(220208004), 220225-c3867-427(220209007); 220225-c3867-428(220209002), 220225-c3867-428(220209002), 220225-c3867-429(220209002); 220225-c3867-429(220209002), 220225-c3867-430(220209008), 220225-c3867-431(220210004); 220225-c3867-434(220204008), 220225-c3867-436(220204008), 220225-c3867-437(220208007); 220225-c3867-438(220206002), 220225-c3867-442(220209008), 220225-c3867-448(220204008); 220228-c3867-309(220221004), 220228-c3867-310(220221004).Retention samples from the reported batch were checked, no related issues were found, and all buffer tubes were normal.Based on the customer's feedback, the supplier conducted an investigation on the 14 possible batches of extraction buffer used.They reviewed the production records for that 14 batches and all of them were produced in february 2022.However, on february 2, 2023, improvement measures had been taken to address the issue of possible insects in the buffer tube.Supplier's detailed analysis was as follows: 1) the filling workshop was a clean workshop, and there were mosquito control lamps being turned on all day for pest controls, reducing the possibility of flying insects entering.2) in the injection molding workshop, if the operator failed to seal the product in a timely manner, it may cause flying insects to enter inside.3) the inspector did not identify the defective one.Supplier preventive and corrective measures are as follow: 1) draft the quality alert and issue a warning to the workshop.2) train operators to clarify the method and requirement of product packaging.3) train inspectors to increase their quality awareness.In this follow-up report, the following information has been updated from the initial report upon completion of the internal investigation.

• 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
• MDR Report Key: 17087591
• MDR Text Key: 316983600
• Report Number: 2531491-2023-00580
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

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 Lot Number: COV2020172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2023
• Initial Date FDA Received: 06/08/2023
• Supplement Dates Manufacturer Received: 04/14/2023
• Supplement Dates FDA Received: 06/14/2023
• 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