BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH COVID-19 ANTIGEN RAPID TEST

    MDR report key: 15249274 · Received August 17, 2022

    Report

    Report Number
    MW5111543
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    August 15, 2022
    Report Date
    August 15, 2022
    Manufacturer
    IHEALTH
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USED TWO BOXES (3 TESTS) OF THE IHEALTH COVID-19 ANTIGEN RAPID TEST. NONE OF THE TESTS SHOWED CONTROL LINES, INDICATING THE TEST DID NOT WORK. NOT SURE IF THIS IS INDICATIVE OF THE EXPIRATION DATE "NOT" BEING CONSISTENT WITH 6 MONTH EXTENSION. THE EXPIRATION DATE ON THE BOX IS 22-06-2027, BUT THAT WAS EXTENDED 6 MONTHS BY FDA. THE LOT NUMBER IS 213C021228. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848256 IHEALTH COVID-19 ANTIGEN RAPID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP IHEALTH 213C021228
    1848257 IHEALTH COVID-19 ANTIGEN RAPID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP IHEALTH 213C021228
    1848258 IHEALTH COVID-19 ANTIGEN RAPID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP IHEALTH 213C021228

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown