BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

    MDR report key: 22125652 · Received June 2, 2025

    Report

    Report Number
    3013756811-2025-96855
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 15, 2025
    Report Date
    June 2, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED WHILE THE CUSTOMER WAS NOT OUTSIDE OF LABELED OPERATING ALTITUDE RANGE. REPORTEDLY, AN OBSTRUCTION WAS BLOCKING THE SPEAKER HOLES. THE CUSTOMER'S BLOOD GLUCOSE WAS 120-287 MG/DL. AFTER REMOVING THE OBSTRUCTION FROM THE SPEAKER HOLES, THE ALARM CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719321 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown