BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 22506981 · Received July 15, 2025

    Report

    Report Number
    3013756811-2025-167883
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    July 5, 2025
    Report Date
    October 8, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152319810
    PMA / PMN Number
    K203234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ¿ PUMP DECLARED A CARTRIDGE CHANGE ERROR. ¿ DID THE ISSUE CAUSE THE CUSTOMER¿S BG TO EXCEED 500 MG/DL (27.7 MMOL/L)? ¿ YES ¿ CUSTOMER'S BG DUE TO THE ISSUE - SPECIFIC VALUE UNKNOWN. VALUE DISPLAYED "HIGH" ¿ WHAT ACTIONS DID CUSTOMER TAKE TO ADDRESS HIGH BG? - CORRECTION INJECTION VIA MDI ¿ DID CUSTOMER REQUIRE ASSISTANCE FROM 3RD PARTY? - NO ¿ CTS INSTRUCTED CALLER TO REMOVE CARTRIDGE FROM PUMP AND INSPECT O-RING AT BOTTOM OF CARTRIDGE ¿ IS THE CARTRIDGE O-RING IN PLACE AND UNDAMAGED? ¿ YES ¿ DOES THE CALLER WEAR THEIR PUMP IN A CASE? ¿ NO. ¿ CTS INSTRUCTED CALLER TO INSPECT THE PNEUMATIC TAP AREA ON THE PUMP. ¿ IS THERE A CARTRIDGE O-RING ON THE PNEUMATIC TAP OR OTHER DEBRIS IN THE AREA? ¿ NO. CTS INSTRUCTED CALLER TO USE AN ALCOHOL WIPE OR LINT-FREE CLOTH TO CLEAN THE PNEUMATIC TAP AREA ON THE PUMP ¿ CTS INSTRUCTED CALLER TO ATTACH CARTRIDGE TO THE PUMP AND CONFIRM IT IS SNAPPED FULLY INTO PLACE. ¿ CTS INSTRUCTED CALLER TO FOLLOW ON-SCREEN INSTRUCTIONS AND COMPLETE LOAD PROCESS ON THE PUMP ¿ WAS CALLER ABLE TO SUCCESSFULLY LOAD THE CARTRIDGE ONTO THE PUMP? ¿ NO ¿ DID CALLER COMPLETE NEW CARTRIDGE FILL WITH CTS IN STEP #6? ¿ NO ¿ PRODUCT 1: CARTRIDGE, T:SLIM, T:LOCK, 10 PACK, GLOBAL ¿ CTS ASSISTED CALLER IN FILLING AND LOADING A NEW CARTRIDGE. ¿ WAS CALLER ABLE TO SUCCESSFULLY LOAD THE CARTRIDGE ONTO THE PUMP? ¿ NO, CTS TO REFER CALLER TO CSA FOR ESCALATED TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771645 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 19 YR Unknown Other TANDEM - CARTRIDGE.