BEUDAMED
    FDA Adverse Event Death Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6797718 · Received August 16, 2017

    Report

    Report Number
    3007981285-2017-23880
    Event Type
    Death
    Date Received
    August 16, 2017
    Date of Event
    July 22, 2017
    Report Date
    August 16, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 WAS HOSPITALIZED DUE TO ELEVATED BLOOD GLUCOSE (BG) LEVELS IN THE 1000 MG/DL RANGE AND DIABETIC KETOACIDOSIS (DKA). THE CUSTOMER SUBSEQUENTLY PASSED AWAY. REPORTEDLY, THE CAUSE OF DEATH WAS DUE TO DKA AND HYPERTENSION. THE CAUSE OF THE HIGH BG WAS UNKNOWN. HOWEVER, PER THE TANDEM CLINICAL DIABETES SPECIALIST (CDS), IT IS POSSIBLE THAT THE CUSTOMER WAS NO LONGER MANAGING BG LEVELS OR TREATING FOR ELEVATED BG LEVELS. THE CUSTOMER HAD ADVANCED PARKINSON'S DISEASE AND REQUESTED THAT NO LIFE SAVING MEASURES BE TAKEN. NO TREATMENT WAS ADMINISTERED FOR ELEVATED BG LEVEL, DKA, OR HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579414 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000354

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| H