BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15380409 · Received September 8, 2022

    Report

    Report Number
    3013756811-2022-98071
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    May 20, 2022
    Report Date
    August 16, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    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 THE BATTERY GAUGE WAS FLUCTUATING AND THAT THE PUMP SHUT OFF UNEXPECTEDLY. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. IT WAS ALSO REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 300 UNITS OF INSULIN DURING THE LOAD SEQUENCE. THE CUSTOMER RE-LOADED THE CARTRIDGE TO RESOLVE THE ISSUE. THE CUSTOMER'S BLOOD GLUCOSE WAS 120 - 330 MG/DL. IT WAS ALSO REPORTED THAT THE INSULIN GAUGE WAS INTERMITTENTLY INACCURATE. CUSTOMER DECLINED TO TROUBLESHOOT THE ISSUE WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2107891 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female