BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 19742358 · Received July 15, 2024

    Report

    Report Number
    3008573045-2024-00022
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 12, 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

    IHEALTH LABS QA HAS DETERMINED THAT THE IHEALTH COVID-19 ANTIGEN RAPID TEST IS AUTHENTIC AS IT WAS PURCHASED FROM AMAZON. THE USER CONDUCTED TESTS ON JUNE 23 AND JUNE 25, AND THE RESULTS WERE NEGATIVE; 7.2 PCR TESTING WAS CONDUCTED AND THE RESULT WAS POSITIVE; AFTER THE COMPLETION OF THE PCR TEST, THE IHEALTH COVID-19 ANTIGEN RAPID TEST WAS USED AGAIN FOR DETECTION, AND THE RESULT WAS NEGATIVE; THE USER DID NOT SPECIFY A SPECIFIC DATE FOR RETESTING. THE INCUBATION PERIOD OF NOVEL CORONAVIRUS IS USUALLY 1-14 DAYS, AND THE ONSET OF THE DISEASE WITHIN 3-7 DAYS IS A PEAK PERIOD, WHICH MEANS THAT MOST PATIENTS WILL HAVE SYMPTOMS WITHIN THIS PERIOD. THE MANUFACTURER RETESTED THE LOT (241CO20115) SAMPLES AT 2024-06-16 AND NO FALSE NEGATIVE WERE DETECTED. THEREFORE, IT CANNOT BE RULED OUT THAT USERS MAY HAVE CONDUCTED TESTS IN THE EARLY AND LATE STAGES OF SYMPTOMS, WITH LOW VIRUS LOADS, RESULTING IN INACCURATE TEST RESULTS.

    Description of Event or Problem · 0

    EVENT DETAILS: WE PURCHASED A 5 PACK OF YOUR COVID TEST. MY WIFE STARTED FEELING POORLY JUNE 23, WITH A TEMPERATURE. SHE TOOK A COVID TEST AND IT CAME OUT NEGATIVE. TWO DAYS LATER, WE TRIED AGAIN AND IT WAS NEGATIVE. STILL FEELING POORLY A WEEK LATER, WE WENT TO URGENT CARE AND THEY SUGGESTED WE TEST HER, EVEN THOUGH BOTH EARLIER TESTS CAME BACK NEGATIVE. THEIR TEST WAS POSITIVE. WE WERE SHOCKED AND AS SOON AS WE GOT BACK FROM URGENT CARE, WE DECIDED TO TRY THE TEST AGAIN TO SEE IF IT'S WORKING PROPERLY. IT AGAIN CAME BACK NEGATIVE, SO CLEARLY THE PACKAGE WE RECEIVED IS FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391460 IHEALTH Coronavirus antigen detection test system. QKP ANDON MEDICAL CO.,LTD ICO-3000 241CO20115

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male