BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 18191445 · Received November 22, 2023

    Report

    Report Number
    3013756811-2023-166493
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    October 19, 2023
    Report Date
    November 22, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000091
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. ROOT CAUSE: COLD INSULIN THE CARTRIDGE USER GUIDE CAUTIONS THAT INSULIN SHOULD BE AT ROOM TEMPERATURE BEFORE FILLING A CARTRIDGE. ONLY USE U-100 HUMALOG OR U-100 NOVOLOG WITH YOUR PUMP. ONLY U-100 HUMALOG AND NOVOLOG HAVE BEEN TESTED AND FOUND TO BE COMPATIBLE FOR USE IN THE PUMP. USE OF INSULIN WITH LESSER OR GREATER CONCENTRATION CAN RESULT IN UNDER DELIVERY OR OVER DELIVERY OF INSULIN. THIS CAN CAUSE HYPOGLYCEMIA (LOW BG) OR HYPERGLYCEMIA (HIGH BG) EVENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 100 UNITS OF INSULIN DURING THE LOAD SEQUENCE. REPORTEDLY, CUSTOMER LOADED COLD INSULIN INTO THE CARTRIDGE. REPORTEDLY, THE CUSTOMER IS USING FIASP INSULIN. TANDEM TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT FIASP INSULIN IS OFF LABEL PER THE USER GUIDE. A NEW CARTRIDGE WAS LOADED TO RESOLVE THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 150-199 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673708 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 60458774 00389152000091

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female INSULIN: FIASPINFUSION SET: TRUSTEEL