BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13010584 · Received December 15, 2021

    Report

    Report Number
    3013756811-2021-137181
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    December 3, 2021
    Report Date
    December 15, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING RESULTING IN THE PUMP SHUTTING DOWN. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 132-133 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911205 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female