BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 15155219 · Received August 3, 2022

    Report

    Report Number
    3008573045-2022-00185
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 6, 2022
    Report Date
    August 3, 2022
    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 NO MEDICAL INTERVENTION OR TREATMENT HAS BEEN PROVIDED; THE CURRENT STATUS OF THE USER/PATIENT WAS UNKNOWN TO DATE. 2 LOT NUMBER: 221CO20216 HAS NOT BEEN IDENTIFIED 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. 3 IFU STATES A FALSE NEGATIVE OR INVALID RESULT MAY OCCUR IF TOO LITTLE SOLUTION IS ADDED TO THE TEST CARD. A FALSE NEGATIVE OR FALSE POSITIVE 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. 4 TEST TO THE PRODUCTION BATCH OF PRODUCT RETENTION SAMPLES (LOT:221CO20216) , THE TEST WAS PASS.

    Description of Event or Problem · 0

    EVENT :THE SITE/USER WAS NOTED TO HAVE REPORTED VIA EMAIL, AS FOLLOWS: " I TESTED POSITIVE YESTERDAY AFTER DEVELOPING GI SYMPTOMS AND HEADACHE. UPON GETTING A POSITIVE RESULT FROM A QUICKVUE AT HOME OTC COVID-19 TEST, A CLOSE FRIEND ASK ME TO TEST USING HER IHEALTH COVID-10 ANTIGEN RAPID TEST TO TEST THE QUALITY OF THE RESULTS. IT GAVE A NEGATIVE RESULT. THE NEXT MORNING (THIS MORNING), I AM STILL FEELING IL AND RETESTED WITH BOTH PROVIDERS. I AGAIN GOT A POSITIVE WITH THE QUICKVUE AND A NEGATIVE WITH THE IHEALTH. MY FRIEND THERE ALSO TESTED WITH QUICKVUE AND GOT A NEGATIVE FYI, SO I DON'T THINK MY POSITIVES WERE FALSE POSITIVES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869815 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000 221CO20216

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown Hospitalization