BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 21453348 · Received February 24, 2025

    Report

    Report Number
    3013756811-2025-40298
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    February 4, 2025
    Report Date
    February 25, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000107
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (H6) REMOVE CODES 2885, 1503, 67. ADD CODES 2993, 61. (H6) REMOVE CODES 2885, 1503, 67. ADD CODES 2993, 61.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY RESULTING IN THE PUMP SHUTTING OFF. THE CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS ¿HIGH¿; HOWEVER, A SPECIFIC VALUE WAS NOT PROVIDED. CUSTOMER ADMINISTERED A CORRECTION INJECTION TO ADDRESS THE ELEVATED BG. TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT INDICATED THAT PUMP BATTERY WAS DEPLETING NORMALLY BASED ON SETTINGS AND CUSTOMER USAGE. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402826 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00389152000107

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female