BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 23659636 · Received November 26, 2025

    Report

    Report Number
    3013756811-2025-267875
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    December 1, 2023
    Report Date
    November 26, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000077
    PMA / PMN Number
    K250792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED INTERMITTENTLY THAT THE CONTROL-IQ ALGORITHM DELIVERED AN AUTO-BOLUS, INCREASED BASAL, DECREASED BASAL AND SUSPENDED BASAL DELIVERY IN RESPONSE TO THE CONTINUOUS GLUCOSE MONITOR (CGM) SENSOR READING; HOWEVER, THE CGM SENSOR READING WAS INACCURATE. REPORTEDLY, THE CGM BLOOD GLUCOSE (BG) READING WAS 200-215 MG/DL, AND THE METER BG READING WAS AROUND 45-50 MG/DL AND A SECOND CGM BG READING WAS A LEVEL THAT WAS DISPLAYED AS ¿LOW¿; HOWEVER, A SPECIFIC VALUE WAS NOT PROVIDED AND THE METER BG READING WAS 80-120 MG/DL. THIS LEVEL OF INACCURACY DOES NOT PRESENT SIGNIFICANT MEDICAL RISK ACCORDING TO THE PARKES ERROR GRID. BG WAS ADDRESSED VIA CONSUMPTION OF CARBOHYDRATES AND JUICE. SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT DID NOT IDENTIFY ANY ADDITIONAL ISSUES WITH THE PUMP OR RELATED SUPPLIES. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2569074 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152000077

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other