BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTEP COVID-19 ANTIGEN PEN

    MDR report key: 20840699 · Received December 4, 2024

    Report

    Report Number
    3014862351-2024-00019
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    November 1, 2024
    Report Date
    December 4, 2024
    Manufacturer
    AZURE BIOTECH, INC.
    Product Code
    QKP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION WAS PERFORMED ON PRODUCT FROM THE SAME LOT AND ALL PRODUCTS MET SPECIFICATIONS. BASED ON THE TESTING RESULTS OF PRODUCT FROM THE SAME LOT, THE COVID-19 ANTIGEN TEST (LOT I2408056) SHOWED ACCEPTABLE PERFORMANCE, AND NO FALSE POSITIVE OR FALSE POSITIVE OCCURRED DURING THE WHOLE 15 MIN WHEN TESTING LOW POSITIVE CONTROL, HIGH POSITIVE CONTROL, AND NEGATIVE CLINICAL SAMPLES.

    Description of Event or Problem · 0

    USER PURCHASED 2 FASTEP COVID 19 ANTIGEN PEN HOME TEST AS THEY WERE HAVING SYMPTOMS. THE USER TOOK TWO OF THE TESTS WHICH PROVIDED A NEGATIVE TEST RESULT. THE USER THEN WENT TO THE DOCTOR'S OFFICE AND THE RAPID TEST WAS POSITIVE. USER THEN CAME HOME AFTER THE POSITIVE AT THE DOCTOR'S OFFICE AND TRIED ANOTHER TEST AND IT ALSO READ NEGATIVE. PRODUCT WAS FROM LOT I2408056.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840022 FASTEP COVID-19 ANTIGEN PEN CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP AZURE BIOTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other