BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTEP COVID-19 ANTIGEN HOME TEST

    MDR report key: 20840635 · Received December 4, 2024

    Report

    Report Number
    3014862351-2024-00017
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    August 2, 2024
    Report Date
    December 4, 2024
    Manufacturer
    AZURE BIOTECH, INC.
    Product Code
    QKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 AG RAPID TEST (LOT I2301009) SHOWED ACCEPTABLE PERFORMANCE, AND NO FALSE POSITIVE OR FALSE POSITIVE OCCURRED DURING THE WHOLE 30 MIN WHEN TESTING NEGATIVE CLINICAL SAMPLES, EVEN SOME CHALLENGING SPECIMENS (VERY STICKY, OVER-DOSE SAMPLE VOLUME OF SWAB).

    Description of Event or Problem · 0

    USER RECEIVED POSITIVE COVID TEST RESULT FROM USING THIS TEST DEVICE AND PERFORMED A PCR TEST TO VERIFY AND RECEIVED A NEGATIVE COVID RESULT. THE USER FEEDBACK IS THAT THE FASTEP COVID-19 ANTIGEN HOME TEST PROVIDED A FALSE POSITIVE RESULT. PRODUCT USED WAS FROM LOT I2301009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942130 FASTEP COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP AZURE BIOTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown Other