BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

    MDR report key: 21172354 · Received January 16, 2025

    Report

    Report Number
    3013756811-2025-17386
    Event Type
    Injury
    Date Received
    January 16, 2025
    Date of Event
    August 18, 2024
    Report Date
    January 16, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152319513
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL OF 800-899 MG/DL. CAUSE OF BG LEVEL WAS NOT KNOWN. CUSTOMER ADMINISTERED A BOLUS VIA THE PUMP TO ADDRESS THE ISSUE AND WENT TO THE EMERGENCY ROOM. CUSTOMER WAS SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT AND TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. CUSTOMER WAS DISCHARGED APPROXIMATELY 2-3 DAYS LATER WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791283 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152319513

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female INSULIN TYPE: NOVOLOG / NOVORAPID.