BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 20294468 · Received September 24, 2024

    Report

    Report Number
    3013756811-2024-178437
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 24, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM (ER) AND WAS SUBSEQUENTLY HOSPITALIZED WITH A BLOOD GLUCOSE (BG) LEVEL OF OVER 600 MG/DL WITH HIGH KETONES IDENTIFIED AS LIFE THREATENING BY A HEALTHCARE PROVIDER. ADDITIONALLY, THE CUSTOMER EXPERIENCED "VISION AND WALKING IS NOT GREAT"; CAUSE OF BG WAS UNKNOWN. THE CUSTOMER CHANGED INFUSION SET PRIOR TO GOING TO THE ER TO ADDRESS BG, AND WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN AND INSULIN INJECTIONS WHILE IN THE HOSPITAL. CUSTOMER WAS DISCHARGED 08/30/2024 WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE. RECOMMENDATION WAS MADE TO CONSULT WITH A HEALTHCARE PROVIDER REGARDING DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290349 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male