BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 22394060 · Received July 3, 2025

    Report

    Report Number
    3013756811-2025-157348
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    June 28, 2025
    Report Date
    July 3, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152319810
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR WAS SUBMITTED IN ERROR. ALLEGED ISSUE DID NOT CAUSE OR CONTRIBUTE TO SERIOUS INJURY AND DOES NOT HAVE THE POTENTIAL TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY. THIS EVENT DOES NOT MEET MDR REQUIREMENTS AS DEFINED BY 21 CFR 803. REMOVE DEVICE CODE A070504

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE. REPORTEDLY, THE CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176945 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 24 YR Female