BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 16572366 · Received March 20, 2023

    Report

    Report Number
    3008573045-2023-00010
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    May 22, 2022
    Report Date
    March 20, 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

    1 INITIAL REPORT SUGGESTED THERE WERE NO MEDICAL INTERVENTION OR TREATMENT PROVIDED; THE CURRENT STATUS OF THE NUMBER OF PATIENT IS UNKNOWN LOT NUMBER: 211CO21229 HAS NOT BEEN IDENTIFIED BY IHEALTH LABS, INC., AS A COUNTERFEIT PRODUCT, SO IT IS SAFE TO CONCLUDE THAT THE DEVICE/KIT RECEIVED IS A VALID IHEALTH LABS, INC., MANUFACTURED TEST KIT PRODUCT. 2 CUSTOMER/USER MAY HAVE NOT FOLLOWED THE INSTRUCTIONS ACCURATELY, POSSIBLY CAUSING THE POSITIVE TEST RESULT/OUTCOME WHEN THE TEST ANTIGEN KIT WAS USED ALTHOUGH THIS HAS NOT BEEN CONFIRMED 3 AS NOTED IN THE IFU, UNDER STEP 6 READ RESULT: RESULTS SHOULD NOT BE READ AFTER 30 MINUTES (RESULTS SHOWS AT 2X MAGNIFICATION). NOTE: A FALSE NEGATIVE OR FALSE POSITIVE RESULT MAY OCCUR IF THE TEST RESULT IS READ BEFORE 15 MINUTES OR AFTER 30 MINUTES. 4 TEST TO THE PRODUCTION BATCH OF PRODUCT RETENTION SAMPLES (LOT:211CO21229) , THE TEST WAS PASS.

    Description of Event or Problem · 0

    THE USER WAS NOTED TO HAVE REPORTED VIA EMAIL, AS FOLLOWS: WE THOUGHT YOU WOULD WANT TO KNOW THAT MY SON TOOK THREE OF YOUR RAPID COVID TESTS ON WEDNESDAY, AND ALL THREE PRODUCED A FADED BLUE LINE SUGGESTING HE HAD COVID. WE SENT HIM FOR A PCR TEST ON THE SAME DAY, AND IT CAME BACK NEGATIVE THAT NIGHT. ON THURSDAY MORNING, HE TOOK ANOTHER ONE OF YOUR RAPID TESTS AND IT CAME BACK NEGATIVE. AND THURSDAY AFTERNOON, HE TOOK ANOTHER PCR TEST WHICH ALSO CAME BACK NEGATIVE. ALL OF THE RAPID TESTS HE USED (THE THREE THAT SHOWED A POSITIVE LINE AND THE ONE THAT DIDN'T) WERE FROM THE SAME LOT NUMBER: 211CO21229-05. THE ONLY EXPLANATION WE CAN THINK OF IS THAT YOUR TESTS WERE FAULT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892878 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000 211CO21229-05

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female