BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 16953227 · Received May 18, 2023

    Report

    Report Number
    3013756811-2023-68557
    Event Type
    Injury
    Date Received
    May 18, 2023
    Date of Event
    April 6, 2023
    Report Date
    May 18, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00850006613700
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 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 OF 850 MG/DL WITH MODERATE TO HIGH KETONES WHICH WERE IDENTIFIED MY A HEALTH CARE PROFESSIONAL AS LIFE THREATENING. THE CUSTOMER ATTEMPTED TO SELF-TREAT WITH A MANUAL DOSE INJECTION BUT WAS TREATED INTRAVENOUSLY WITH FLUIDS OF SALINE AND INSULIN IN THE ICU. THE CUSTOMER WAS RELEASED FROM THE ICU ON (B)(6) 2023 WITH ISSUE RESOLVED AND NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907845 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717 00850006613700

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female INSULIN: HUMALOG.