BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16939859 · Received May 16, 2023

    Report

    Report Number
    3013756811-2023-66395
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    April 24, 2023
    Report Date
    May 16, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. PER TANDEM USER GUIDE: 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 150 UNITS OF INSULIN DURING THE LOAD SEQUENCE. 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 140-189 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864480 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 60432510 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female INSULIN: FIASPINFUSION SET: TRUSTEEL