BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 19971934 · Received August 13, 2024

    Report

    Report Number
    3013756811-2024-152014
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    May 6, 2024
    Report Date
    August 29, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL OF 800-899 MG/DL. CAUSE OF BG LEVEL WAS NOT KNOWN. CUSTOMER WENT TO THE EMERGENCY ROOM WITH HIGH KETONES AND WAS SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. CUSTOMER WAS DISCHARGED 3 DAYS LATER WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. DATE OF EVENT IS APPROXIMATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895529 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male INSULIN: NOVOLOG/NOVORAPID