BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST

    MDR report key: 17405929 · Received July 25, 2023

    Report

    Report Number
    MW5120159
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    July 11, 2023
    Report Date
    July 21, 2023
    Manufacturer
    HEALGEN SCIENTIFIC LLC
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I CONTRACTED COVID-19 ABOUT A WEEK AGO. UNFORTUNATELY, THE CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST FAILED TO DETECT THE INFECTION DUE TO AN INSUFFICIENT QUANTITY OF BUFFER LIQUID IN THE TEST TUBE. AFTER THE SWAB WITH THE MUCUS SAMPLE WAS INSERTED INTO THE TUBE, IT WAS UNABLE TO PROVIDE EVEN A SINGLE DROP OF LIQUID FOR THE TEST STRIP. I THINK THAT THE INSUFFICIENT BUFFER FLUID WAS CAUSED BY MANUFACTURING ERROR OR SIMPLY DRIED OUT OVER TIME. LOT NUMBERS PRINTED ON THE BOX: 2202062EUA, 2202141EUA LOT NUMBERS PRINTED ON THE BUFFER TUBES: 2022010390, EXPIRY DATE: 2024, 06, 2022020329, EXPIRY DATE: 2024, 07. SELF-TEST FAILED TO DETECT THE INFECTION DUE TO AN INSUFFICIENT QUANTITY OF BUFFER LIQUID IN THE TEST TUBE. REFERENCE REPORT: MW5120160.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2325551 CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP HEALGEN SCIENTIFIC LLC 2022010390

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention