BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12925205 · Received December 3, 2021

    Report

    Report Number
    3013756811-2021-131104
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    November 16, 2021
    Report Date
    December 3, 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 INTERMITTENT CARTRIDGE ALARMS OCCURRED DURING BASAL INSULIN DELIVERY AND DURING THE LOAD SEQUENCE. THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 251-253 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820365 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 44 YR Female