BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 8625500 · Received May 20, 2019

    Report

    Report Number
    3013756811-2019-27005
    Event Type
    Injury
    Date Received
    May 20, 2019
    Date of Event
    December 22, 2018
    Report Date
    May 20, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007257
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 WAS HOSPITALIZED DUE TO EXPERIENCING AN ELEVATED BLOOD GLUCOSE (BG) LEVEL RANGING BETWEEN 650-700 MG/DL AND DIABETIC KETOACIDOSIS (DKA); HEALTHCARE PROVIDER ALLEGED BG/DKA WAS CAUSED BY AN UNSPECIFIED PUMP FAILURE. NO ISSUES OBSERVED WITH THE CARTRIDGE, INFUSION SET OR CANNULA. CORRECTION BOLUSES WERE DELIVERED AND MANUAL INJECTIONS WERE ADMINISTERED TO ADDRESS BG/DKA PRIOR TO THE HOSPITALIZATION. AN INSULIN DRIP AND INTRAVENOUS FLUIDS WERE ADMINISTERED TO ADDRESS BG/DKA. CUSTOMER WAS RELEASED FROM THE HOSPITAL 2-3 DAYS LATER WITH NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417417 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007257

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| R INFUSION SET: AUTOSOFT 90, INSULIN: HUMALOG