BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY

    MDR report key: 22862548 · Received August 21, 2025

    Report

    Report Number
    3013756811-2025-198372
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    August 11, 2025
    Report Date
    August 21, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152407319
    PMA / PMN Number
    K232380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CUSTOMER UPDATED PERSONAL PROFILE AND BIQ/CIQ SETTINGS, INCLUDING SLEEP SCHEDULES. BLOOD GLUCOSE LEVEL REPORTED AT 40 MG/DL. CUSTOMER CONSUMED ORANGE JUICE AND CANDY TO ADDRESS LOW BLOOD GLUCOSE AND DID NOT REQUIRE THIRD-PARTY ASSISTANCE. CTS ASSISTED IN UPDATING BIQ/CIQ SETTINGS AND ADVISED CHECKING WITH HEALTHCARE PROVIDER WHEN UPDATING SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456119 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00389152407319

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other