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

Catalog Number	COV-S23010H2
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Interference and cross-reactivity substances were also studied in our analytical study.No false positive results occurred according to the testing procedure in pi.
Event or Problem Description
Fastep covid rats ref cov-s23010h2, lot i2301009, mfg 2023-01-03, exp 2025-01-02 obtained from amazon appeared prone to false positives.Between (b)(6) 2024, positive results from fastep covid rats ((b)(6) 2024 faint, (b)(6) 2024 vibrant) could not be replicated with tests from other vendors such as medstar rapid pcr ((b)(6) 2024), abbott binaxnow ((b)(6) 2024), boson ((b)(6) 2024), and inbios ((b)(6) 2024).These findings suggest that either the fastep tests in question were exceptionally sensitive compared to tests by other manufacturers, -or- that the fastep tests were more likely to produce false positives for whatever reason.If test results were false, they delayed proper treatment.Mild symptoms were experienced during this time frame, including a low fever, headaches, sore throat, congestion near the nose and ears.The cause of the low fever was explicitly disputed by a doctor; a second doctor had increased the dosage of amitriptyline from 10mg to 20mg daily during this time period shortly before the low fever, and that medication could have caused the body to retain more heat than normal.Treatment for ongoing allergy issues was partially suspended during this time, which plausibly could have contributed to some of the other symptoms.The household cat has a chronic lung bacterial infection and has been on antibiotics long-term.

• Brand Name: FASTEP COVID-19 ANTIGEN HOME TEST
• Common Device Name: FASTEP COVID TEST
• Manufacturer (Section D): AZURE BIOTECH INC; 10400 main st.; houston TX 77025
• Manufacturer Contact: karla munoz ; 10400 main st.; houston, TX 77025 ; 7135615529
• MDR Report Key: 20494177
• Report Number: 3014862351-2024-00010
• Device Sequence Number: 3615314
• Product Code: QYT
• UDI-Device Identifier: 00810022630358
• UDI-Public: 810022630358
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Remedial Action: Inspection,Notification
• Type of Report: Initial
• Report Date (Section B): 10/02/2024

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: 01/01/2025
• Device Catalogue Number: COV-S23010H2
• Device Lot Number: I2301009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2023
• 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: 34 YR
• Patient Sex: Male
• Patient Weight: 120 KG