BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARETOUCH

    MDR report key: 17298803 · Received July 11, 2023

    Report

    Report Number
    3016774562-2023-01430
    Event Type
    Injury
    Date Received
    July 11, 2023
    Report Date
    July 11, 2023
    Manufacturer
    TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT - LIMITED DATA AVAILABLE. THE CUSTOMER NOTED THAT THE DEVICE PROVIDED INACCURATE READINGS. DIFFERENT TEST STRIPS YIELDED DRASTICALLY DIFFERENT READINGS EVEN THOUGH THE SAME SAMPLE WAS USED AT THE TIME.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT - LIMITED DATA AVAILABLE "THE READINGS ARE VERY DIFFERENT. FOR THE SAME PERSON AND THE SAME BLOOD DRAWN, DIFFERENT STRIPS ARE YIELDING DRASTIC DIFFERENCES. 165, 103, 241 ETC. THE DEVICE IS NOT AVERAGING OR NOT EVEN CLOSE TO ACCURATE. IM NOT SURE HOW TO GO FORWARD WITH THIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1873993 CARETOUCH BLOOD GLUCOSE MONITOR NBW TIANJIN EMPECS MEDICAL DEVICE CO., LTD. CT210

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown