BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 25096215 · Received May 6, 2026

    Report

    Report Number
    3013756811-2026-82411
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    May 2, 2026
    Report Date
    May 27, 2026
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152319810
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REMOVE CODE A141204, ADD CODE A0401.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARTRIDGE WAS CRACKED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER PERFORMED A CARTRIDGE CHANGE TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176933 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00389152319810

    Patients

    Seq Age Sex Outcome Treatment
    1