BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 22490789 · Received July 13, 2025

    Report

    Report Number
    3013756811-2025-166079
    Event Type
    Injury
    Date Received
    July 13, 2025
    Date of Event
    July 7, 2025
    Report Date
    July 13, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K203234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM (ER) WITH A BLOOD GLUCOSE (BG) LEVEL OF 435 MG/DL; CAUSE WAS UNKNOWN. IN AN ATTEMPT TO TREAT BG PRIOR TO THE ER, THE CUSTOMER DELIVERED A CORRECTION BOLUS. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN TO ADDRESS THE ELEVATED BG. CUSTOMER WAS DISCHARGED LATER THE SAME DAY 7/72025 HOWEVER, THE ISSUE WAS NOT RESOLVED. RECOMMENDATION WAS MADE TO CONSULT WITH A HEALTHCARE PROVIDER REGARDING DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147377 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention NOVOLOG / NOVORAPID - INSULIN.