BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH COVID-19 ANTIGEN RAPID TEST

    MDR report key: 15379694 · Received September 7, 2022

    Report

    Report Number
    MW5111901
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Date of Event
    August 31, 2022
    Report Date
    September 3, 2022
    Manufacturer
    IHEALTH LABS, INC.
    Product Code
    QLW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE TESTED BOTH OF OUR CHILDREN ON WEDS (B)(6) 2022 WITH THE IHEALTH COVID-19 ANTIGEN RAPID TEST, ONE WITH AN EXPIRATION DATE OF 9/6/2022. BOTH TESTED POSITIVE, WITH A FAINT LINE. BOTH CHILDREN WERE ASYMPTOMATIC. WE ALSO TESTED OUR DAUGHTER WITH THE CUE SYSTEMS NAAT ON WEDS NIGHT AND SHE WAS NEGATIVE. WE THEN RE-TESTED THEM ON THURS (B)(6) 2022 WITH THE QUICKVUE RAPID ANTIGEN TEST, AND THEY WERE BOTH NEGATIVE. WE THEN DID A PCR TEST ON FRIDAY (B)(6) 2022, AND THEY WERE BOTH NEGATIVE. WE ALSO TESTED THEM WITH AN IHEALTH COVID-19 ANTIGEN RAPID TEST ON FRIDAY (B)(6) 2022, WITH AN EXPIRATION DATE IN 2023, AND THEY WERE NEGATIVE. THUS, I WOULD HYPOTHESIZE THAT THE SHELF LIFE OF THE IHEALTH TESTS IS TOO AGGRESSIVE, AND THE SEEMINGLY OBVIOUS FALSE POSITIVES WE EXPERIENCED WERE RELATED TO THE PRODUCT BEING NEAR ITS EXPIRATION DATE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2644903 IHEALTH COVID-19 ANTIGEN RAPID TEST COVID-19 TEST HOME COLLECTION KIT DEVICES QLW IHEALTH LABS, INC.
    2644904 IHEALTH COVID-19 ANTIGEN RAPID TEST COVID-19 TEST HOME COLLECTION KIT DEVICES QLW IHEALTH LABS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female