BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM MOBI INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY

    MDR report key: 23724113 · Received December 4, 2025

    Report

    Report Number
    3013756811-2025-272206
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 24, 2025
    Report Date
    January 26, 2026
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K240309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CALLER REPORTED THAT TANDEM MOBI CARTRIDGE ALARM WAS TRIGGERED, BUT THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE ISSUE OCCURRED DURING THE LOAD PROCESS, AND ALTHOUGH THE CUSTOMER HAD NOT PREVIOUSLY REPORTED THIS SPECIFIC ALARM CODE WITH THIS PUMP, CONSECUTIVE CARTRIDGE ALARMS WERE CONFIRMED. TECHNICAL SUPPORT DECIDED TO REPLACE THE PUMP, AS IT WAS STILL UNDER WARRANTY, WITH AN EXPIRATION DATE OF SEPTEMBER 19, 2028. THE CALLER WAS PROVIDED INSTRUCTIONS ON HOW TO PUT THE PUMP INTO STORAGE MODE AND INFORMED ABOUT THE STEPS TO TAKE WITH THE REPLACEMENT PUMP. THE CUSTOMER, WHO USES MULTIPLE DAILY INJECTIONS AS A BACKUP THERAPY, WAS ALSO INSTRUCTED TO RETURN THE PROBLEMATIC PUMP TO TANDEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2863062 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 36 YR Male NOVOLOG / NOVORAPID - INSULIN| UNOMEDICAL - INFUSION SET