BEUDAMED
    FDA Adverse Event Death Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 7512904 · Received May 14, 2018

    Report

    Report Number
    3013756811-2018-16036
    Event Type
    Death
    Date Received
    May 14, 2018
    Date of Event
    March 27, 2018
    Report Date
    May 14, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY. CAUSE OF DEATH WAS DUE TO DIABETIC KETOACIDOSIS (DKA). DUE TO INSURANCE ISSUES, THE CUSTOMER WAS UNABLE TO MAINTAIN ADEQUATE SENSOR SUPPLIES. THE CUSTOMER WAS UNDERGOING DIALYSIS AND DUE TO THE LACK OF SENSOR SUPPLIES, THE CUSTOMER WAS UNABLE TO MANAGE CHANGING INSULIN NEEDS DURING DIALYSIS, AND SUBSEQUENTLY WENT INTO DKA AND WAS HOSPITALIZED. THE PATIENT LOST A DEGREE OF COGNITIVE FUNCTIONING WITH DKA AND THE HEALTHCARE PROVIDER DECIDED TO DISCONTINUE PUMP THERAPY WHILE HOSPITALIZED. THE CUSTOMER WAS DISCHARGED FROM HOSPITALIZATION WITH MANUAL INJECTIONS AND THE HCP WAS MONITORING THE PATIENT BEFORE AND AFTER DISCHARGE. HOWEVER, THE CUSTOMER ULTIMATELY PASSED AWAY DUE TO DKA. THE CUSTOMER WAS NOT USING THE PUMP AT THE TIME OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355518 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death| H