MAUDE Adverse Event Report: AZURE BIOTECH, INC. FASTEP COVID-19 ANTIGEN HOME TEST

Catalog Number	COV-S23010H2
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer contacted for a refund/ replacement and additional information through amazon, but no response was provided.
Event or Problem Description
Customer purchased the fastep tests and kept getting negative results even though the lab had already confirmed a positive result.Decided to use another brand and the results for those were positive as expected.

• Brand Name: FASTEP COVID-19 ANTIGEN HOME TEST
• Common Device Name: COVID-19 ANTIGEN HOME TEST
• Manufacturer (Section D): AZURE BIOTECH, INC.; 10400 main st; houston TX 77025
• Manufacturer Contact: frank luo ; 10400 main st; houston, TX 77025 ; 7135615529
• MDR Report Key: 20798256
• Report Number: 3014862351-2024-00014
• Device Sequence Number: 7809304
• Product Code: QYT
• UDI-Device Identifier: 00810022630358
• UDI-Public: 810022630358
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EUA220191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/02/2025
• Device Catalogue Number: COV-S23010H2
• Device Lot Number: I2301009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose