BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM MOBI INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY

    MDR report key: 23248108 · Received October 8, 2025

    Report

    Report Number
    3013756811-2025-232728
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 8, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K240309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 WITH A BLOOD GLUCOSE (BG) LEVEL OF "250-350" MG/DL WITH HIGH KETONES; CAUSE WAS UNKNOWN. REPORTEDLY, THE CUSTOMER ALSO HAD PNEUMONIA WHICH WAS STATED AS ONE OF THE REASONS THEY WERE HOSPITALIZED. THEY WERE TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN TO ADDRESS THE ELEVATED BG. CUSTOMER WAS DISCHARGED ON (B)(6)2025 WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE. A SYSTEM CHECK IDENTIFIED THE PUMP TO BE WORKING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2566786 TANDEM MOBI INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1004000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention| H