BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON/GO COVID-19 ANTIGEN SELF-TEST

    MDR report key: 13257803 · Received January 13, 2022

    Report

    Report Number
    MW5106652
    Event Type
    Malfunction
    Date Received
    January 13, 2022
    Date of Event
    January 11, 2022
    Report Date
    January 11, 2022
    Manufacturer
    INTRIVO
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USED INTRIVO/ACCESSBIO'S ON/GO COVID-19 ANTIGEN SELF TEST. THE TEST WAS NEGATIVE, HOWEVER, THE APP INCORRECTLY LOGGED THE TEST AS POSITIVE AND LOGGED THE TEST RESULT MULTIPLE TIMES AS POSITIVE. ACCESS, BIO, INC. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857569 ON/GO COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP INTRIVO CP21L08
    857570 ON/GO APP MEDICAL DEVICE DATA SYSTEM QKP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male