BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 6427794 · Received March 23, 2017

    Report

    Report Number
    3007981285-2017-07861
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    February 24, 2017
    Report Date
    March 23, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 27 MG/DL AND THE CUSTOMER LOST CONSCIOUSNESS. PARAMEDICS WERE CALLED AND A GLUCOSE SHOT AND INTRAVENOUS FLUIDS WERE ADMINISTERED. ORANGE JUICE WAS CONSUMED. THE CUSTOMER WAS NOT TAKEN TO THE EMERGENCY ROOM/HOSPITAL. THE CUSTOMER HAD BEEN TAKING A MEDICATION FOR CUSHING'S DISEASE AND A HEALTHCARE PROVIDER (HCP) STATED THAT THE MEDICATION MAY CAUSE THE BG LEVEL TO RUN LOW. THE HCP HAD ADJUSTED THE PUMP SETTINGS TO ACCOMMODATE FOR THE LOW BG CAUSED BY THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210014 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R