BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17297934 · Received July 11, 2023

    Report

    Report Number
    3013756811-2023-94820
    Event Type
    Injury
    Date Received
    July 11, 2023
    Date of Event
    April 9, 2023
    Report Date
    July 11, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007318
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM (ER) WITH AN ELEVATED BLOOD GLUCOSE LEVEL THAT RANGED FROM 950-957 MG/DL. REPORTEDLY, CUSTOMER ALLEGED AN UNSPECIFIED CARTRIDGE ALARM CAUSED THE HIGH BG. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. CUSTOMER WAS RELEASED FROM THE ER 5-6 HOURS LATER WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE. CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148495 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00853052007318

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female INSULIN: HUMALOG.