BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 8798992 · Received July 17, 2019

    Report

    Report Number
    3013756811-2019-40786
    Event Type
    Injury
    Date Received
    July 17, 2019
    Date of Event
    June 26, 2019
    Report Date
    July 17, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL OVER 600 MG/DL AND DIABETIC KETOACIDOSIS (DKA) RESULTING IN A HOSPITALIZATION. HEALTHCARE PROVIDER CONSIDERED DKA DANGEROUS. BG/DKA WAS CAUSED BY CUSTOMER RUNNING OUT OF INSULIN AS THE CUSTOMER HAD FORGOTTEN TO PERFORM A CARTRIDGE CHANGE. CUSTOMER SET A TEMPORARY BASAL RATE TO ADDRESS BG/ DKA. CUSTOMER WAS TREATED WITH AN INSULIN DRIP. CUSTOMER WAS RELEASED FROM THE HOSPITAL ON JUNE 9TH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592616 T:SLIM X2 INSULIN PUMP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R