BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM MOBI INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY

    MDR report key: 22540478 · Received July 18, 2025

    Report

    Report Number
    3013756811-2025-172547
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    June 24, 2025
    Report Date
    July 18, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152365619
    PMA / PMN Number
    K240309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. THE CUSTOMER¿S BLOOD GLUCOSE WAS 800-899. REPORTEDLY, THE CUSTOMER LOST CONSCIOUSNESS AND A FAMILY MEMBER CALLED EMERGENCY SERVICES (EMS). THE CUSTOMER WAS THEN TAKEN TO THE EMERGENCY ROOM BY EMS AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL WITH A BG OF 700 MG/DL. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. CUSTOMER WAS DISCHARGED ON (B)(6) 2025 WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302507 TANDEM MOBI INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1004000 00389152365619

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Life Threatening| R| H HUMALOG - INSULIN| TANDEM - CARTRIDGE| UNOMEDICAL - INFUSION SET