BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 22408695 · Received July 6, 2025

    Report

    Report Number
    3013756811-2025-158795
    Event Type
    Malfunction
    Date Received
    July 6, 2025
    Date of Event
    June 26, 2025
    Report Date
    October 7, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B5: PUMP BATTERY HAD SHUT OFF. H6: MEDICAL DEVICE CODE A141204 ADDED.

    Description of Event or Problem · 0

    A MALFUNCTION OCCURRED WITH A PUMP THAT WOULD NOT CHARGE, AND THE DEVICE BECAME VERY HOT. THERE WAS NO REPORTED IMPACT ON THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE PUMP WAS SET TO BE RETURNED FOR EVALUATION, AND A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2764060 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown