BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH COVID-19 ANTIGEN RAPID TEST KIT

    MDR report key: 14021248 · Received April 5, 2022

    Report

    Report Number
    MW5108767
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    April 2, 2022
    Report Date
    April 2, 2022
    Manufacturer
    IHEALTH LABS, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR REPORT MW5108767 ON: 04/14/2022, PROCODE QKP.

    Description of Event or Problem · 0

    IN-HOME COVID-19 TEST HAS THE WRONG INSTRUCTIONS. PACKAGE CONTAINS UNFILLED SAMPLE COLLECTION TUBES BUT THE INSTRUCTIONS ARE FOR PREFILLED TUBES. IT TOOK A BIT TO FIGURE OUT WHY THE DIRECTIONS DIDN'T MATCH THE SUPPLIES, I FIGURED IT OUT BUT MANY WON'T AND WILL EITHER WASTE THE TEST OR DO IT INCORRECTLY AND MAY GET INCORRECT RESULT. IHEALTH COVID-19 ANTIGEN RAPID TEST SEE PHOTO FOR LOT NUMBER ETC. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165500 IHEALTH COVID-19 ANTIGEN RAPID TEST KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP IHEALTH LABS, INC. 222CO20212
    1907212 IHEALTH COVID-19 ANTIGEN RAPID TEST KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP IHEALTH LABS, INC. 222CO20212

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown