BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12540747 · Received September 28, 2021

    Report

    Report Number
    3013756811-2021-104919
    Event Type
    Injury
    Date Received
    September 28, 2021
    Date of Event
    September 11, 2021
    Report Date
    September 28, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING BASAL DELIVERY WITH MULTIPLE CARTRIDGES. SUBSEQUENTLY, THE CUSTOMER WENT TO THE EMERGENCY ROOM DUE TO A BLOOD GLUCOSE LEVEL OF 190-240 MG/DL. CUSTOMER WAS GIVE AN INSULIN PEN WHILE IN THE ER TO ADDRESS BG LEVEL AND CONTINUE INSULIN THERAPY. THE CUSTOMER WAS RELEASED FROM THE ER 2 HOURS LATER WITH NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439392 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention INSULIN: NOVOLOG| INSULIN: NOVOLOG