BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16629772 · Received March 28, 2023

    Report

    Report Number
    3013756811-2023-42624
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    March 4, 2023
    Report Date
    March 28, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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 OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED THE PUMP SUPPLIES TO ADDRESS THE ISSUE. REPORTEDLY, THE CUSTOMER IS USING FIASP INSULIN. TANDEM TECHNICAL SUPPORT INFORMED CUSTOMER THAT USING FIASP INSULIN IS OFF LABEL PER THE USER GUIDE. REPORTEDLY, THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY ADMITTED INTO THE INTENSIVE CARE UNIT, FOR DIABETIC KETO ACIDOSIS (DKA). CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 180-224 MG/DL WITH HIGH KETONES. KETONE LEVELS IDENTIFIED BY THEIR HEALTH CARE PROVIDER AS LIFE THREATENING. CUSTOMER ATTEMPTED TO ADDRESS THE ELEVATED BG BY DELIVERING A CORRECTION BOLUS, AND MANUAL INSULIN INJECTION. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF D5 HALF NORMAL SALINE, MAGNESIUM, POTASSIUM, AND INSULIN. TREATMENT RESOLVED THE ISSUES. CUSTOMER WAS RELEASED ON (B)(6) 2023 WITH NO PERMANENT DAMAGE. TANDEM TECHNICAL SUPPORT WALKED CALLER THROUGH A PUMP SYSTEM CHECK AND CONFIRMED PUMP IS FUNCTIONING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427948 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0740117 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Life Threatening| H| R INFUSION SET: AUTOSOFT XC.INSULIN: FIASP.