BEUDAMED
    FDA Adverse Event Death Summary report: N

    T-SLIM X2 INSULIN PUMP

    MDR report key: 21584041 · Received March 12, 2025

    Report

    Report Number
    MW5167559
    Event Type
    Death
    Date Received
    March 12, 2025
    Date of Event
    August 31, 2024
    Report Date
    March 7, 2025
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    QFG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD REPORTEDLY COMPLAINED OF MALFUNCTIONING INSULIN PUMP WITH RECURRENT DKA (DIABETIC KETOACIDOSIS). EXPIRED WITH DKA. CALLED TANDEM MULTIPLE TIMES FOR PUMP INTERROGATION AND THEY HAVE NO FOLLOWED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112681 T-SLIM X2 INSULIN PUMP ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE, INC. U100

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Death| O