BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21439467 · Received February 21, 2025

    Report

    Report Number
    3013756811-2025-29833
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    December 3, 2024
    Report Date
    February 21, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED. H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. THE CUSTOMER'S BLOOD GLUCOSE 110-415 MG/DL. THE CARTRIDGE WAS RELOADED, AND INSULIN DELIVERY WAS RESUMED HOWEVER THE ALTITUDE ALARM RECURRED. REPORTEDLY, THE CUSTOMER CONTACTED THE HEALTHCARE PROVIDER TO OBTAIN ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045461 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female