BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 9740795 · Received February 21, 2020

    Report

    Report Number
    3013756811-2020-16318
    Event Type
    Injury
    Date Received
    February 21, 2020
    Date of Event
    January 24, 2020
    Report Date
    February 21, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 OF OVER 500 MG/DL AND DIABETIC KETOACIDOSIS (DKA). CAUSE OF BG/DKA WAS NOT KNOWN. CUSTOMER'S HEALTHCARE PROVIDER ALLEGED BG/DKA MAY HAVE BEEN CAUSED BY THE PUMP; HOWEVER THIS COULD NOT BE CONFIRMED. CORRECTION BOLUS WERE DELIVERED TO ADDRESS BG/DKA. CUSTOMER WAS SUBSEQUENTLY HOSPITALIZED AND TREATED WITH INTRAVENOUS INSULIN DRIP. CUSTOMER WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2020 WITH NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204565 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 35 YR Hospitalization| R