BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16181400 · Received January 17, 2023

    Report

    Report Number
    3013756811-2023-07854
    Event Type
    Injury
    Date Received
    January 17, 2023
    Date of Event
    December 25, 2022
    Report Date
    January 17, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 INTERMITTENT OCCLUSION ALARMS OCCURRED. SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT (TTS) AND NO ISSUES WERE IDENTIFIED. CUSTOMER CHANGED THE PUMP SUPPLIES AND SUCCESSFULLY RESUMED INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 350-524 MG/DL. ELEVATED BLOOD GLUCOSE LEVELS WERE ADDRESSED BY CORRECTION BOLUS VIA THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819552 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 W0385615 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other INFUSION SET: AUTOSOFT XCINSULIN: NOVOLOG/ NOVO R