BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23039994 · Received September 12, 2025

    Report

    Report Number
    3013756811-2025-215317
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    September 4, 2025
    Report Date
    November 26, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152407319
    PMA / PMN Number
    K232380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A DUPLICATE REPORT AND WAS FULLY REPORTED ON 3013756811-2025-213716.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER'S PUMP SCREEN WOULD NOT TURN ON, AS IT REMAINED DARK DESPITE VARIOUS TROUBLESHOOTING STEPS. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069402 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 25 YR Male