BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 23106251 · Received September 21, 2025

    Report

    Report Number
    3008573045-2025-00054
    Event Type
    Malfunction
    Date Received
    September 21, 2025
    Date of Event
    August 6, 2025
    Report Date
    September 8, 2025
    Manufacturer
    ANDON MEDICAL CO.,LTD
    Product Code
    QMN
    PMA / PMN Number
    EUA230053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1.CUSTOMER SAYS FOUR TESTS USED WERE NEGATIVE RESULTS BUT LATER TESTED POSITIVE AT DOCTOR. 2.THE MODEL OF TEST KIT IS THE IHEALTH COVID-19 FLU A&B 3-IN-1 (COV-FLU-2),THE TYPE OF FALSE NEGATIVE WAS NOT SPECIFIED. 3.TYPE OF TEST TAKEN AT DOCTOR WAS NOT SPECIFIED,UNSURE IF IT IS A MOLECULAR TEST. 4.THE MANUFACTURER RETESTED THE LOT (242CF10902) WITH FLUA,FLUB AND COVID POSITIVE SAMPLES ,NO FALSE NEGATIVE WERE DETECTED.

    Description of Event or Problem · 0

    EVENT DETAILS: CUSTOMER SAID TO USE FOUR TESTS OF IHEALTH COVID-19 FLU A&B 3-IN-1 WERE NEGATIVE RESULTS BUT LATER TESTED POSITIVE AT DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2701204 IHEALTH COVID-19 Multi-Analyte Antigen Device QMN ANDON MEDICAL CO.,LTD ICF-3000 242CF10902

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown