BEUDAMED
    FDA Adverse Event Death Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5650200 · Received May 12, 2016

    Report

    Report Number
    3007981285-2016-79422
    Event Type
    Death
    Date Received
    May 12, 2016
    Date of Event
    April 18, 2016
    Report Date
    April 18, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CONTACT THAT THE CUSTOMER HAD BEEN RECEIVING INCOMPLETE BOLUS ALERTS. A TANDEM CLINICAL DIABETES SPECIALIST HAD ASSISTED THE CUSTOMER'S SON WITH ADDRESSING THE ALERTS. THE CUSTOMER HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE (BG) LEVELS (500 MG/DL) AND DIABETIC KETOACIDOSIS (DKA). ON (B)(6) 206, THE CUSTOMER EXPIRED AT HOME. THE CAUSE OF DEATH WAS LISTED AS END STAGE RENAL DISEASE. THE CUSTOMER'S SON THOUGHT THAT THE HIGH BG AND DKA MAY HAVE CONTRIBUTED TO THE DEATH. THERE WAS NO DEVICE MALFUNCTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304738 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death