BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 23713650 · Received December 4, 2025

    Report

    Report Number
    3013756811-2025-271848
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 4, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152407319
    PMA / PMN Number
    K232380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CALLER REPORTED AN ISSUE WITH LOW BLOOD GLUCOSE, REACHING 50 MG/DL, WHICH WAS DUE TO BIQ/CIQ SETTINGS. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL, AS THE CUSTOMER CONSUMED CARBOHYDRATES TO ADDRESS THE LOW LEVEL. CTS ASSISTED THE CALLER IN UPDATING BASAL RATE AND BIQ/CIQ SETTINGS, RECOMMENDING CONSULTATION WITH THE CUSTOMER'S HEALTHCARE PROVIDER FOR FUTURE UPDATES, WHICH THE CALLER ACKNOWLEDGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2807606 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 59 YR Male Other