BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTEP COVID-19 ANTIGEN PEN HOME TEST

    MDR report key: 20530543 · Received October 25, 2024

    Report

    Report Number
    3014862351-2024-00003
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    September 6, 2024
    Report Date
    October 24, 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

    CUSTOMER CONTACTED THROUGH AMAZON AND NO RESPONSE WAS PROVIDED RESULTING IN INSUFFICIENT INFORMATION FOR AN INVESTIGATION OR REFUND.

    Description of Event or Problem · 0

    USER PROVIDED FEEDBACK ON PRODUCT THAT THEY TESTED NEGATIVE ON THIS TEST AND POSITIVE ON OTHERS, CLASSIFYING THIS FEEDBACK AS A FALSE NEGATIVE. USER PROVIDED FURTHER FEEDBACK THAT IT COULD BE THE SWAB THAT PROVIDED USABILITY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818614 FASTEP COVID-19 ANTIGEN PEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP AZURE BIOTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown Other