BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE A

    MDR report key: 21071754 · Received January 3, 2025

    Report

    Report Number
    3013756811-2025-08649
    Event Type
    Injury
    Date Received
    January 3, 2025
    Date of Event
    December 15, 2024
    Report Date
    January 3, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 PUMP WOULD NOT GO PAST THE FILL TUBING STEP DURING THE LOAD PROCESS; CAUSE WAS NOT KNOWN. CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 780-788 MG/DL. CUSTOMER WENT TO THE EMERGENCY ROOM WITH KETONES (AMOUNT WAS NOT KNOWN) IDENTIFIED AS LIFE-THREATENING BY A HEALTHCARE PROVIDER AND WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. CUSTOMER WAS DISCHARGED THE SAME DAY WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE. TANDEM TECHNICAL SUPPORT DID A FULL PUMP SYSTEM CHECK AND CONFIRMED THAT PUMP WAS FUNCTIONING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639172 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE A ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female INSULIN TYPE: NOVOLOG / NOVORAPID