BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 24333969 · Received February 13, 2026

    Report

    Report Number
    3013756811-2026-29125
    Event Type
    Injury
    Date Received
    February 13, 2026
    Date of Event
    February 5, 2026
    Report Date
    February 13, 2026
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000091
    PMA / PMN Number
    K203234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER'S BG VALUE DISPLAYED AS "LOW"; HOWEVER, SPECIFIC VALUE WAS NOT PROVIDED. CAUSE OF LOW BG WAS UNKNOWN. CUSTOMER CONSUMED GLUCOSE TABLETS, PB CRACKERS, PB BREAD, OJ, GRAPES, COOKIES AND LUNCHABLE TO ADDRESS BG. RECOMMENDATION WAS MADE TO CONSULT WITH A HEALTHCARE PROVIDER TO DISCUSS DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397760 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152000091

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Other