BEUDAMED
    FDA Adverse Event Death Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6283225 · Received January 27, 2017

    Report

    Report Number
    3007981285-2017-02570
    Event Type
    Death
    Date Received
    January 27, 2017
    Date of Event
    September 26, 2016
    Report Date
    January 27, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION WAS RECEIVED ON 01/30/2017 FROM (B)(6). THE CUSTOMER WAS DISCONNECTED FROM THE PUMP AND WAS NOT USING IT AT THE TIME OF DEATH AS THE CUSTOMER COULD NOT AFFORD TO USE THE PUMP DUE TO AN ISSUE WITH INSURANCE COVERAGE. A FEW WEEKS PRIOR TO DEATH, THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS (DKA), SECONDARY TO THE ABILITY TO AFFORD MEDICATION. THE CUSTOMER WAS TREATED WITH LEVEMIR AND NOVOLOG AND RELEASED FROM HOSPITALIZATION WITH INSULIN PENS. ON THE DATE OF DEATH, THE CUSTOMER AWOKE VOMITING AND IN DKA. PER THE PATHOLOGICAL SUMMARY ON THE AUTOPSY REPORT, THE CAUSE OF DEATH WAS HYPERGLYCEMIA (632 MG/DL) WITH DKA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2016. THE CAUSE OF DEATH IS UNKNOWN. IT IS UNKNOWN IF THE CUSTOMER WAS WEARING THE PUMP AT THE TIME OF DEATH. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66763 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Death