BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM MOBI INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY

    MDR report key: 22893199 · Received August 26, 2025

    Report

    Report Number
    3013756811-2025-201112
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    August 7, 2025
    Report Date
    August 26, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K240309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CONTROL-IQ WAS NOT ADJUSTING INSULIN DELIVERY AS EXPECTED, DESPITE A TEMP RATE SET TO 0%, CIQ ON, AND SLEEP MODE ACTIVE. THE SYSTEM OVERRODE THE TEMP RATE AND ADJUSTED BASAL INSULIN BASED ON CIQ THRESHOLDS. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2704745 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 58 YR Male