BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 22967149 · Received September 4, 2025

    Report

    Report Number
    3013756811-2025-208686
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    September 3, 2025
    Report Date
    January 9, 2026
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000077
    PMA / PMN Number
    K203234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A HIGH BLOOD GLUCOSE LEVEL WAS REPORTED WHEN THE VALUE DISPLAYED "HIGH"; ALTHOUGH SPECIFIC VALUE WAS NOT PROVIDED. THE CUSTOMER ADMINISTERED A CORRECTION BOLUS VIA THE PUMP AND INSPECTED VARIOUS COMPONENTS AS INSTRUCTED BY TECHNICAL SUPPORT, WHO FURTHER EDUCATED THE CUSTOMER ON THE PROPER TIMELINE FOR CARTRIDGE USE. THE CUSTOMER AGREED TO REPLACE SUPPLIES AS NECESSARY AND RESUME INSULIN, WITH TECHNICAL SUPPORT SET TO PROVIDE REPLACEMENT SUPPLIES AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017631 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152000077

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other HUMALOG - INSULIN.| UNOMEDICAL - INFUSION SET.