BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16724702 · Received April 12, 2023

    Report

    Report Number
    3013756811-2023-49932
    Event Type
    Injury
    Date Received
    April 12, 2023
    Date of Event
    March 7, 2023
    Report Date
    April 12, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    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 CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL OF 50 MG/DL. THE CUSTOMER CONSUMED CARBOHYDRATES TO ADDRESS THE LOW BG. THE CAUSE OF THE EVENT WAS DUE TO THE CUSTOMER RECEIVING CORRECTION BOLUS DURING THE NIGHT AND SLEEP MODE WAS NOT ON AS EXPECTED. TANDEM TECHNICAL SUPPORT (CTS) WAS ABLE TO DETERMINE DURING TROUBLESHOOTING THAT THE CUSTOMER PLACED THE PUMP IN SLEEP MODE, AND SHORTLY AFTER TURNED THE CONTROL IQ SOFTWARE OFF TO TAKE A BATH. CUSTOMER ASSUMED THAT ONCE CONTROL IQ SOFTWARE WAS TURNED BACK ON, THE PUMP WOULD AUTOMATICALLY RESUME IN SLEEP MODE. CTS EDUCATED CUSTOMER ON SLEEP MODE AND EXPLAINED THAT IF CONTROL IQ IS TURNED OFF AFTER THE PROGRAMED SLEEP SCHEDULE, IT MUST BE TURNED BACK ON MANUALLY. THE CUSTOMER ACKNOWLEDGED AND CONTINUED USING THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2283797 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 63 YR Female