BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 25171021 · Received May 14, 2026

    Report

    Report Number
    3013756811-2026-87155
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    January 30, 2026
    Report Date
    May 14, 2026
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152319810
    PMA / PMN Number
    K250792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED IN THE INTENSIVE CARE UNIT WITH A BLOOD GLUCOSE (BG) LEVEL BETWEEN 250-380 MG/DL WITH KETONES OF AN UNSPECIFIED SIZE ON (B)(6) 2026. CAUSE WAS NOT KNOWN. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN TO ADDRESS THE ELEVATED BG. CUSTOMER WAS DISCHARGED ON (B)(6) 2026 WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE, HOWEVER, THE CUSTOMER WAS READMITTED LATER THE SAME DAY. THE CUSTOMER WAS RE-HOSPITALIZED WITH A BG LEVEL BETWEEN 122-145 MG/DL. THE CUSTOMER RECEIVED THE SAME TREATMENT AND WAS DISCHARGED ON (B)(6) 2026 WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381743 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