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

Catalog Number	COV-S23010H2
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer contacted for a refund/ replacement through amazon, but no response was provided.
Event or Problem Description
Parent has given feedback that their preschooler has falsely tested positive during two different periods in a matter of 30 days.

• Brand Name: FASTEP COVID-19 ANTIGEN HOME TEST
• Common Device Name: FASTEP 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: 20635475
• Report Number: 3014862351-2024-00007
• Device Sequence Number: 20674329
• 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): 11/07/2024

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?: No
• Operator of Device: Lay User/Patient
• 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: 09/27/2024
• Initial Report FDA Received Date: 11/07/2024
• 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 Age: 4 YR
• Patient Sex: Prefer Not To Disclose