BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 16402195 · Received February 20, 2023

    Report

    Report Number
    3008573045-2023-00006
    Event Type
    Malfunction
    Date Received
    February 20, 2023
    Report Date
    February 18, 2023
    Manufacturer
    ANDON MEDICAL CO.,LTD
    Product Code
    QKP
    PMA / PMN Number
    EUA210470
    Removal / Correction Number
    MW5113331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. A NEGATIVE TEST RESULT INDICATES NO ANTIGENS FOR COVID-19 WERE DETECTED. THE TEST IS POSSIBLE TO GIVE A NEGATIVE RESULT THAT IS INCORRECT IN SOME PEOPLE AND NEGATIVE RESULTS ARE PRESUMPTIVE AND MANY NEED TO BE CONFIRMED WITH A MOLECULAR TEST. IF RECEIVE A NEGATIVE RESULT, SHOULD TEST AGAIN IN 24-48 HOURS . A FALSE NEGATIVE RESULT MAY OCCUR IF THE TEST RESULT IS READ BEFORE 15 MINUTES OR AFTER 30 MINUTES. THERE WAS NO INDICATION TO CONFIRM OR DENY IF THE USER/PATIENT HAD UTILIZED THE TEST KIT APPROPRIATELY AS PER INTENDED USE OR OFF USE. 2. NO REPORTS OF ADVERSE RELATED EVENTS WITH EITHER PATIENT OR USER (NO PATIENT DEATH, INJURY, ALLERGIC REACTION(S), OR ANY MEDICAL INTERVENTION PROVIDED). 3. THERE WAS NO INFORMATION PROVIDED REGARDING THE LOT NUMBER OF THE ANTIGEN TEST KIT; THEREFORE COULD NOT CONCLUDE IF THE TEST KIT WAS A COUNTERFEIT PRODUCT OR NOT. THE USER/PATIENT DID NOT SHARE THE CONTACT INFORMATION FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    THE EVENT DESCRIPTION: COVID TEST KIT - FALSE NEGATIVE FIRST TWO DAYS OF SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643840 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown