BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 24766207 · Received April 2, 2026

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    3013756811-2026-60338
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 2, 2026
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152319513
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PUMP EXPERIENCED REPEATED MALFUNCTION ALARMS WITH CODE 12 AND ASSOCIATED FAULT ID, WITH NO NOTABLE EVENTS OCCURRING BEFOREHAND. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER PLANNED TO USE MULTIPLE DAILY INJECTIONS AS BACKUP INSULIN THERAPY, RESETTABLE MALFUNCTION WAS NOT FURTHER RESET, AND TECHNICAL SUPPORT ARRANGED SHIPMENT OF REPLACEMENT PUMP WITH UPDATED SOFTWARE, PROVIDED INSTRUCTIONS FOR STORAGE MODE AND RETURN OF PROBLEMATIC PUMP WITHIN TEN DAYS, AND ADVISED CUSTOMER TO REENTER PUMP SETTINGS AND RECONNECT CONTINUOUS GLUCOSE MONITOR ON REPLACEMENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823324 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152319513

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female