BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 21863041 · Received April 18, 2025

    Report

    Report Number
    3008573045-2024-00034
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    August 28, 2024
    Report Date
    September 27, 2024
    Manufacturer
    ANDON HEALTH CO., LTD.
    Product Code
    QKP
    PMA / PMN Number
    EUA210470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. CUSTOMER BELIEVES TEST OF (B)(6) 2024 WAS A FALSE POSITIVE BASED ON 3 PIECES OF INFORMATION. 1) T LINE WAS NOT PINK OR PURPLE AS DESCRIBED IN THE INSTRUCTIONS FOR USE. 2) PREVIOUS IHEALTH TESTS WERE NEGATIVE. 3) FOLLOW UP ANTIGEN TEST OF ABBOTT BRAND WAS NEGATIVE. 2. CUSTOMER NO FOLLOW UP PCR TEST WAS PERFORMED. 3. THE MANUFACTURER RETESTED THE LOT (231CO20904) SAMPLES, NO FALSE POSITIVE WERE DETECTED.

    Description of Event or Problem · 0

    CUSTOMER BELIEVES TEST OF (B)(6) 2024 WAS A FALSE POSITIVE BASED ON 3 PIECES OF INFORMATION 1. T LINE WAS NOT PINK OR PURPLE AS DESCRIBED IN THE INSTRUCTIONS FOR USE. 2. PREVIOUS IHEALTH TESTS WERE NEGATIVE. 3. FOLLOW UP ANTIGEN TEST OF ABBOTT BRAND WAS NEGATIVE. NO FOLLOW UP PCR TEST WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680673 IHEALTH Coronavirus antigen detection test system. QKP ANDON HEALTH CO., LTD. ICO-3000 231CO20904

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown