BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARE TOUCH

    MDR report key: 17342186 · Received July 18, 2023

    Report

    Report Number
    3016774562-2023-01569
    Event Type
    Injury
    Date Received
    July 18, 2023
    Report Date
    July 18, 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 "CUSTOMER COMPLAINT: I ALWAYS HAVE TO GO THROUGH ABOUT 5 STRIPS TO GET ONE THAT DON'T THROW AN ERROR. I'VE HAVE TWO DAYS NOW THAT MY SUGAR READS LOW YESTERDAY IT READ 53 RECHECKED IT SAID 35 I FELT FINE. THIS MORNING IT READ 20. RECHECKED IT IMMEDIATELY AND IT READ 173. MY DAUGHTER HAS THE SAME ONE AND IT WORKS FINE FOR HER SO WAS HOPING I CAN TRY ANOTHER ONE."

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT: LIMITED DATA AVAILABLE. THE CUSTOMER HAD TO USE MULTIPLE STRIPS IN ORDER TO GET A RESULT THAT DIDN'T ERROR OUT. WHEN THEY DID GET RESULTS IT WAS INACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754914 CARE TOUCH BLOOD GLUVOSE MONITOR NBW TIANJIN EMPECS MEDICAL DEVICE CO., LTD. CT210

    Patients

    Seq Age Sex Outcome Treatment
    1 Female