BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 14911711 · Received July 4, 2022

    Report

    Report Number
    3008573045-2022-00149
    Event Type
    Malfunction
    Date Received
    July 4, 2022
    Date of Event
    May 10, 2022
    Report Date
    July 4, 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

    IHEALTH LABS, INC., CUSTOMER SERVICE HAS REACHED OUT TO THE SITE VIA EMAIL PROVIDING EDUCATIONAL LITERATURE, I.E., EUA FOR IHEALTH RAPID TEST IFU, AS WELL AS PRACTICALLY EXPLAINING IN DETAIL THAT A NEGATIVE RESULT COULD NOT BE RULED OUT COVID-19 AND NOT THE PRIMARY BASIS FOR TREATMENT OR PATIENT MANAGEMENT DECISIONS. A NEGATIVE RESULT DOES NOT EXCLUDE THE POSSIBILITY OF COVID 19. BASED ON THE INITIAL REPORT PROVIDED, THERE WERE NO REPORTS INDICATING THAT THE USER(S) HAD SOUGHT ADDITIONAL MEDICAL TREATMENT AS A RESULT OF THE POSITIVE TESTS FOLLOWING THE USE OF THE ABBOTT TEST KITS. THERE WAS NO CONFIRMATION TO INDICATE IF THE USER(S) HAVE UTILIZED THE TEST KIT(S) AS DESCRIBED IN THE ENCLOSED IFU, WHICH COULD HAVE POTENTIALLY CAUSED AND/OR CONTRIBUTED TO THE "NEGATIVE" OUTCOME REPORTED. USER(S) CLAIMED "THEY DIDN'T WORK," WHICH COULD POTENTIALLY BE ANY. IHEALTH COULD NOT CONFIRM OR DENY IF THE "DIDN'T WORK" ISSUE WAS INTENDED FOR THE PRODUCT ITSELF OR THE WAY THE USER(S) HAD UTILIZED THE PRODUCT AND DID NOT EXPECT THE RESULTS THE USER(S) WERE HOPING TO SEE. THERE ARE NO ADDITIONAL INFORMATION ,WE WILL FOLLOW-UP.

    Description of Event or Problem · 0

    CUSTOMER FEEDBACK : "MY ONLY PROBLEM WAS THEY DIDN'T WORK. BOTH MY WIFE AND MY FRIENDS' WIFE WERE SICK WITH SYMPTOMATIC COVID. THE IHEALTH TESTS WERE NEGATIVE THREE DAYS IN A ROW. WE FINALLY BOUGHT THE ABBOTT TESTS WHICH WERE BOTH POSITIVE WITHIN A MINUTE OR TWO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161949 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Hospitalization