BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16351917 · Received February 10, 2023

    Report

    Report Number
    3013756811-2023-23632
    Event Type
    Injury
    Date Received
    February 10, 2023
    Date of Event
    January 8, 2023
    Report Date
    February 10, 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
    VT, 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. CUSTOMER CHANGED THE PUMP SUPPLIES TO ADDRESS THE ISSUE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 211-546 MG/DL, WITH LARGE KETONES. ELEVATED BLOOD GLUCOSE LEVELS WERE ADDRESSED BY MANUAL INSULIN INJECTION AND CORRECTION BOLUS VIA THE PUMP. REPORTEDLY, ON (B)(6) 2023 THE CUSTOMER WENT TO THE EMERGENCY ROOM (ER) AND WAS SUBSEQUENTLY ADMITTED INTO THE INTENSIVE CARE UNIT (ICU) DUE TO THE ELEVATED BG. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN, WHICH RESOLVED THE ISSUE AND CUSTOMER WAS RELEASED THE SAME DAY WITH NO PERMANENT DAMAGE. MULTIPLE FOLLOW ATTEMPTS WERE MADE BY TANDEM CUSTOMER TECHNICAL SUPPORT (CTS), TO ACQUIRE ADDITIONAL INFORMATION, HOWEVER, NO RESPONSE WAS RECEIVED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57670 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female Required Intervention| H INSULIN: NOVOLOG / NOVORAPID