BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDICAID COVID-19 RAPID ANTIGEN TEST

    MDR report key: 16641085 · Received March 30, 2023

    Report

    Report Number
    3017887566-2023-00001
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 1, 2022
    Report Date
    March 9, 2023
    Manufacturer
    PHASE SCIENTIFIC INTERNATIONAL LIMITED
    Product Code
    QKP
    PMA / PMN Number
    N/AN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A POSSIBLE FALSE-NEGATIVE RESULT. THE CUSTOMER WAS SYMPTOMATIC AND TESTED WITH THE INDICAID PRODUCT WITH A NEGATIVE RESULT WHILE POSITIVE RESULTS WERE OBTAINED FOR TWO DIFFERENT TEST BRANDS. THERE IS NO INJURY OR HOSPITALIZATION REPORTED BY THE USER. THIS REPORT IS BEING SUBMITTED, PURSUANT TO SECTION IV(Q) OF THE PRODUCT'S LETTER OF AUTHORIZATION, TO REPORT ADVERSE EVENTS INCLUDING OCCURRENCES OF POTENTIAL FALSE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172531 INDICAID COVID-19 RAPID ANTIGEN TEST INDICAID COVID-19 RAPID ANTIGEN TEST QKP PHASE SCIENTIFIC INTERNATIONAL LIMITED 22S0028

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female Other