BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23841934 · Received December 18, 2025

    Report

    Report Number
    3013756811-2025-283299
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    November 11, 2025
    Report Date
    December 18, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000077
    PMA / PMN Number
    K232380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 200-280 UNITS OF INSULIN DURING THE LOAD SEQUENCE. A NEW CARTRIDGE WAS LOADED TO RESOLVE THE ISSUE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256797 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 46 YR Male TANDEM - CARTRIDGE.