FDA Adverse Event Malfunction Summary report: N

FASTEP COVID-19 ANTIGEN HOME TEST

MDR report key: 20190578 · Received September 9, 2024

Report

Report Number
MW5159462
Event Type
Malfunction
Date Received
September 9, 2024
Date of Event
August 2, 2024
Report Date
August 23, 2024
Manufacturer
AZURE BIOTECH INC.
Product Code
QKP
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
VA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

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 AND (B)(6) 2024, POSITIVE RESULTS FROM FASTEP COVID RATS (B)(6) 2024 FAINT, (B)(6) 2024 FAINT, (B)(6) 2024 FAINT, (B)(6) 2024 VIBRANT, (B)(6) 2024 FAINT, (B)(6) 2024 FAINT, (B)(6) 2024 FAINT, (B)(6) 2024 FAINT, (B)(6) 2024 FAINT) 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, (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. REFERENCE REPORTS: MW5159461, MW5159462, MW5159463, MW5159464, MW5159465, MW5159466, MW5159467, MW5159468.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1515784 FASTEP COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP AZURE BIOTECH INC.

Patients

Seq Age Sex Outcome Treatment
1 34 YR Male AMITRIPTYLINE 10MG/DAY| AMOXICILLIN-CLAV 875-125 2X/DAY| BLIS PROBIOTICS THROAT HEALTH K12 | COVIXYL NASAL SPRAY| GENERIC GUMMY MULTIVITAMIN| GENERIC ZYRTEC| LINZESS 72MCG AS NEEDED| LISINOPRIL 10MG/DAY| MELATONIN| PEPPERMINT OIL GELCAPS| PROFI NASAL SPRAY| PROPRANOLOL HCL ER 60MG/DAY| SALINE NASAL RINSE| VARIOUS CANNABINOID EDIBLES| VITAMIN D AS PART OF A BLINDED CLINICAL STUDY