BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16285660 · Received February 2, 2023

    Report

    Report Number
    3013756811-2023-12228
    Event Type
    Injury
    Date Received
    February 2, 2023
    Date of Event
    January 11, 2023
    Report Date
    February 2, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONTROL IQ SOFTWARE INTERMITTENTLY DID NOT ADJUST INSULIN DELIVERY AS INTENDED. REPORTEDLY, INSULIN WAS BEING DELIVERED BASED OFF THE PUMP PERSONAL PROFILE SETTINGS INSTEAD OF CONTROL IQ SETTINGS DESPITE CONTROL IQ BEING TURNED ON. THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE LEVEL. THE CUSTOMER'S CONTINUOUS GLUCOSE MONITOR READ ¿LOW¿, HOWEVER, A SPECIFIC BLOOD GLUCOSE (BG) VALUE WAS NOT PROVIDED. REPORTEDLY, THE CUSTOMER CONSUMED CARBOHYDRATES TO ADDRESS LOW BG. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE PUMP WAS RESET, AND THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901734 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Other