BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH COVID-19 HOME RAPID ANTIGEN TEST

    MDR report key: 14675261 · Received June 10, 2022

    Report

    Report Number
    MW5110243
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    June 4, 2022
    Report Date
    June 8, 2022
    Manufacturer
    IHEALTH LABS, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    [IHEALTH COVID-19 ANTIGEN RAPID TEST] USE FOR COVID-19 UNDER EMERGENCY USE AUTHORIZATION (EUA): IHEALTH COVID-19 ANTIGEN RAPID TEST- SELF TEST. ASYMPTOMATIC INDIVIDUAL, PRE-TRAVEL TESTING. TWO POSITIVE TESTS, SAME LOT NUMBERS, THEN RAN THE TESTS AGAIN WITH REAGENT ONLY, POSITIVE RESULT AS WELL, LEADING TO CONCLUSION THAT IT IS A FP D/T REAGENT OR DETECTOR BASED FLAW. HAD TO GET PCR TESTS AT (B)(6) EACH TO CLEAR THE INDIVIDUALS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965950 IHEALTH COVID-19 HOME RAPID ANTIGEN TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP IHEALTH LABS, INC. ICO-3000 (10): 211CO21215
    1965951 IHEALTH COVID-19 HOME RAPID ANTIGEN TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP IHEALTH LABS, INC. ICO-3000 (10): 211CO21215

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other