BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARE TOUCH

    MDR report key: 17484363 · Received August 8, 2023

    Report

    Report Number
    3016774562-2023-00717
    Event Type
    Injury
    Date Received
    August 8, 2023
    Report Date
    August 8, 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 "DO NOT BUY!!! INACCURATE --- UPDATE, JUST TOOK 4 READINGS, WITHIN 20 SECONDS EACH, 212, 201, 160, 145... WORTHLESS! AT FIRST, I LIKED THE DEVICE, BUT DAYS INTO USE, I HAVE SEEN THAT THE READINGS VARY WIDELY, BY 50+. THESE ARE READINGS USING A NEW STRIP, SAME PRICK, ONE AFTER ANOTHER, EVEN PRICKING AGAIN AND TESTING. I GET 3-4 READINGS THAT VARY BY 30 TO 60 UNITS, WHICH OF COURSE CAN TOTALLY CHANGE THE EVALUATION OF THE BLOOD SUGAR LEVEL."

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT - LIMITED DATA AVAILABLE. CUSTOMER REPORTED INACCURATE READINGS WHILE UTILIZING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457293 CARE TOUCH BLOOD GLUCOSE MONITOR NBW TIANJIN EMPECS MEDICAL DEVICE CO., LTD. CT210

    Patients

    Seq Age Sex Outcome Treatment
    1 Male