BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 16590265 · Received March 22, 2023

    Report

    Report Number
    3008573045-2023-00022
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    September 15, 2022
    Report Date
    March 22, 2023
    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

    INITIAL REPORT SUGGESTED THERE WERE NO MEDICAL INTERVENTION OR TREATMENT PROVIDED; HOWEVER THE CURRENT STATUS OF THE NUMBER OF PATIENT IS UNKNOWN THERE WAS NO INFORMATION PROVIDED REGARDING THE LOT NUMBER OF THE ANTIGEN TEST KIT; THEREFORE COULD NOT CONCLUDE IF THE TEST KIT RECEIVED WAS A COUNTERFEIT PRODUCT OR NOT. INITIAL REPORTS SUGGESTED THAT THE IHEALTH ANTIGEN TEST KIT WAS NOT TAMPERED WITH, ALTERED, OR COMPROMISED, AS NO EVIDENCE THAT THE USER/PATIENT HAD SEEN EVIDENCE OF PRODUCT ALTERATION. 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.

    Description of Event or Problem · 0

    THE USER WAS NOTED TO HAVE REPORTED VIA VOICEMAIL, AS FOLLOWS: "TESTED POSITIVE THE SAME DAY RIGHT AFTER HAVING NEGATIVE RESULTS USING THESE TESTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828007 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown