BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 24779559 · Received April 3, 2026

    Report

    Report Number
    3013756811-2026-60782
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 2, 2026
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152319810
    PMA / PMN Number
    K203234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    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 240-303 MG/DL; CAUSE WAS UNKNOWN. CUSTOMER GAVE A MANUAL INJECTION TO ADDRESS BG. AT THE ER CUSTOMER WAS TREATED WITH LANTUS TO ADDRESS BG. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. RECOMMENDATION WAS MADE TO CONSULT WITH A HEALTHCARE PROVIDER REGARDING DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366087 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00389152319810

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention