BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARETOUCH

    MDR report key: 17162917 · Received June 20, 2023

    Report

    Report Number
    3016774562-2023-01363
    Event Type
    Injury
    Date Received
    June 20, 2023
    Report Date
    June 20, 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 I WOULD LIKE A REPLACEMENT OR A REFUND. THE PRODUCT SAYS MY FATHERS SUGAR IS 500 MORE POINTS THAN IT ACTUALLY IS. WE TESTED IT AGAINST 2 OF HIS PRIMARY DOCTORS MACHINES. WE KNOW THE PRODUCT DOESN'T WORK.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT - LIMITED DATA AVAILABLE . THE CUSTOMER STATED THAT THEIR PARENT ATTEMPTED TO USE THE DEVICE BUT THERE WERE MULTIPLE INSTANCES OF INACCURATE READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710532 CARETOUCH BLOOD GLUCOSE MONITORING KIT NBW TIANJIN EMPECS MEDICAL DEVICE CO., LTD. CT210

    Patients

    Seq Age Sex Outcome Treatment
    1 Female