BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARETOUCH

    MDR report key: 16503579 · Received March 8, 2023

    Report

    Report Number
    3016774562-2023-00543
    Event Type
    Injury
    Date Received
    March 8, 2023
    Report Date
    March 8, 2023
    Manufacturer
    TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT: SHE WENT TO BED AT A 117 AND TESTED WHEN SHE WOKE 13 HOURS LATER, TEENAGERS, AT A 130. I TOLD HER TO DO 3-4 BACK TO BACK RIGHT AFTER THE 130. SHE GOT 109, 107, AND 114. THAT'S QUITE THE RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789801 CARETOUCH BLOOD GLUCOSE TEST SYSTEM NBW TIANJIN EMPECS MEDICAL DEVICE CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown