BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16064269 · Received December 28, 2022

    Report

    Report Number
    3013756811-2022-150037
    Event Type
    Injury
    Date Received
    December 28, 2022
    Date of Event
    October 29, 2022
    Report Date
    December 28, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER TANDEM¿S USER GUIDE: INSULIN SHOULD BE AT ROOM TEMPERATURE BEFORE FILLING CARTRIDGE. 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 REPORT THAT AN OCCLUSION ALARM OCCURRED. THE CUSTOMER WENT TO THE EMERGENCY ROOM AND SUBSEQUENTLY ADMITTED TO THE HOSPITAL¿S INTENSIVE CARE UNIT (ICU) WITH A BLOOD GLUCOSE LEVEL IN THE RANGE OF 500 - 600 MG/DL WITH MODERATE KETONES THAT WERE IDENTIFIED AS LIFE THREATENING MY A HEALTHCARE PROFESSIONAL. THE CUSTOMER WAS TREATED INTRAVENOUSLY WITH FLUIDS OF SALINE AND INSULIN AND WAS RELEASE FROM THE HOSPITAL WITH NO PERMANENT DAMAGE ON (B)(6) 2022. REPORTEDLY, THE CUSTOMER WAS USING COLD INSULIN WHICH IS CONSIDERED OFF LABEL PER THE TANDEM USER GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453450 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Hospitalization| R| L INSULIN TYPE: HUMALOG