BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVO25 COVID RAPID TEST

    MDR report key: 13591750 · Received February 23, 2022

    Report

    Report Number
    MW5107644
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    January 22, 2022
    Report Date
    February 20, 2022
    Manufacturer
    E25BIO, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE TEST GAVE A FALSE NEGATIVE. NEGATIVE TEST RESULTS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944194 EVO25 COVID RAPID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP E25BIO, INC.
    944195 EVO25 COVID RAPID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP E25BIO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female