BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM MOBI INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY

    MDR report key: 24873458 · Received April 14, 2026

    Report

    Report Number
    3013756811-2026-67619
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    April 11, 2026
    Report Date
    April 14, 2026
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152481319
    PMA / PMN Number
    K241078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE, WHICH MEASURED 49 MG/DL, WHILE UPDATING PUMP SETTINGS RELATED TO TIME, PERSONAL PROFILE, OR BIQ/CIQ FEATURES. CUSTOMER TREATED LOW BLOOD GLUCOSE BY CONSUMING CARBOHYDRATES, DID NOT REQUIRE HELP FROM ANOTHER PERSON, AND TECHNICAL SUPPORT ASSISTED WITH UPDATING BIQ/CIQ SETTINGS AND ADVISED CUSTOMER TO CONSULT HEALTHCARE PROVIDER REGARDING ANY FUTURE SETTING CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171943 TANDEM MOBI INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1004000 00389152481319

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other