BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 9349744 · Received November 20, 2019

    Report

    Report Number
    3013756811-2019-78816
    Event Type
    Injury
    Date Received
    November 20, 2019
    Date of Event
    October 25, 2019
    Report Date
    November 20, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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 CONTINUOUS ELEVATED BLOOD GLUCOSE (BG) LEVELS REACHING BETWEEN 450-487 MG/DL AND 3.0 MMOL/L KETONE LEVEL RESULTING IN A HOSPITALIZATION. CAUSE OF BG WAS NOT KNOWN. MULTIPLE SUPPLY CHANGES WERE PERFORMED TO ADDRESS BG. CUSTOMER WAS RELEASED FROM THE HOSPITAL WITH BG BETWEEN 270-271 MG/DL AND 0.5 MMOL/L KETONE LEVEL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145669 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| R INSULIN: NOVORAPID, INFUSION SET: AUTOSOFT 90