BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 21863458 · Received April 18, 2025

    Report

    Report Number
    3008573045-2024-00028
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    August 16, 2024
    Report Date
    September 4, 2024
    Manufacturer
    ANDON MEDICAL CO.,LTD
    Product Code
    QKP
    PMA / PMN Number
    EUA210470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER IS CLAIMING FALSE NEGATIVE AS COMPARED TO POSITIVE TEST RESULTS FROM GENABIO. GENABIO IS A RAPID ANTIGEN TESTS, NOT PCR TEST. NO PCR CONFIRMATION WAS PERFORMED. (B)(6) AT 8:00AM - IHEALTH TEST-EGATIVE; (B)(6) AT 2PM- IHEALTH TEST-NEGATIVE; (B)(6) AT 11PM-IHEALTH TEST- NEGATIVE; (B)(6) AT 2:22AM-IHEALTH TEST-NEGATIVE; (B)(6) 11:36AM-IHEALTH TEST-NEGATIVE; (B)(6) 11:38 AM -GENABIO TEST- POSITIVE. THE MANUFACTURER RETESTED THE LOT (241CO20705) SAMPLES AT (B)(6) 2024 AND NO FALSE NEGATIVE WERE DETECTED.

    Description of Event or Problem · 0

    EVENT DETAILS: ON 8/16/2024 CUSTOMER SUBMITTED THE FOLLOWING MESSAGE TO OUR CUSTOMER SERVICE DEPARTMENT: I WANT A REFUND IMMEDIATELY ON MY AMAZON ORDER. BOUGHT 5 TESTS. I FELT MISERABLE FOR DAYS. I TOOK ALL 5 TESTS, ALL SHOWED NEGATIVE AND I FOLLOWED THE DIRECTIONS TO A T. FINALLY BOUGHT A TEST (DIFFERENT BRAND) FROM A LOCAL STORE. TOOK THAT TEST THE EXACT TIME AS THE IHEALTH TEST. IT WAS GLARINGLY POSITIVE, MEANWHILE THE IHEALTH TEST WAS STILL NEGATIVE. REFUND ME IMMEDIATELY FOR MY DEFECTIVE TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32097 IHEALTH Coronavirus antigen detection test system. QKP ANDON MEDICAL CO.,LTD ICO-3000 241CO20705

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown