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

Lot Number COV1110148

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2022

Event Type  malfunction  

Manufacturer Narrative

No abnormal issue was found in the manufacturing process, technical testing and quality control inspection, and the manufacturing process.1)inavalid test results - the test results of retention samples of cov1110148 met the qc criteria.The complaint issue was not reproduced with the retention samples.The root cause is undertermined.2)the assembly process of the reported lot is completed by the automatic machine, including strip cutting, cassette pressing and pouching of strip and desiccant.Normally the pouch without desiccant would be detected out by the detection sensor.The root cause was not identified.Similar issues will be tracked and trended.

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.When the customer opened the test kit, she noticed the desiccant packet was no included with the test cassette.When the customer performed the test , no control line or test line appeared on the test cassette.The customer had a 2nd kit, that test had the desiccant and worked correctly.I advised the customer that i need to forward this information to the appropriate department for review.Customer will wait for an email response from acon labs regarding this matter.

• 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: 16388131
• MDR Text Key: 309776265
• Report Number: 2531491-2023-00297
• 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: 02/16/2023

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 Expiration Date: 11/18/2021
• Device Lot Number: COV1110148
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2022
• 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