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

Lot Number COV1100082

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Date 12/13/2021

Event Type  malfunction  

Event Description

Invalid result (s).Performed the test procedure and received a band above the letter c rather than level with the letter c.Stated that the band may have been present in the result window prior to performing the test procedure.Possible out of box issue.

Manufacturer Narrative

Per the investigation, no anomalies were found to indicate a systemic issue.The issue was not reproducible with the retention lots, and no root cause was identified with customer error, internal error, or supplier.The severity of potential injury is negligible, and frequency of injury is improbable based on number of similar complaints in the past.The combined frequency and severity present an overall acceptable risk (low), and no further investigation is needed.This is not an mdr because no injury has been reported, and the chance of serious injury is low following proper testing procedure.

• 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: 16387598
• MDR Text Key: 309776517
• Report Number: 2531491-2023-00292
• 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: 10/24/2022
• Device Lot Number: COV1100082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2021
• 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