BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17031277 · Received May 31, 2023

    Report

    Report Number
    3013756811-2023-71427
    Event Type
    Injury
    Date Received
    May 31, 2023
    Date of Event
    May 8, 2023
    Report Date
    May 31, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM (ER) DUE TO A BLOOD GLUCOSE LEVEL THAT RANGED FROM 162-163 MG/DL AND HIGH KETONES. PRIOR TO GOING TO THE ER, THE CUSTOMER DELIVERED A CORRECTION BOLUS TO ADDRESS HIGH BGS. WHILE IN THE ER, CUSTOMER WAS UNDER OBSERVATION, AND DID NOT RECEIVE ADDITIONAL TREATMENT. THE CUSTOMER WAS RELEASED FROM THE ER EIGHT HOURS LATER WITH NO PERMANENT DAMAGE. THE CAUSE OF THE REPORTED ISSUE WAS DUE TO AN OCCLUSION ALARM. PRIOR TO THE REPORT, THE CUSTOMER HAD ALREADY CHANGED THE CARTRIDGE AND INFUSION SET; THEREFORE, NO TROUBLESHOOTING COULD BE PERFORMED BY TANDEM TECHNICAL SUPPORT TO DETERMINE A ROOT CAUSE. THE CUSTOMER ACKNOWLEDGED THE PUMP FUNCTIONED AS INTENDED AND DECLINED TO PERFORM A SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131860 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 4 YR Female