BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15371774 · Received September 7, 2022

    Report

    Report Number
    3013756811-2022-97919
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Date of Event
    August 13, 2022
    Report Date
    August 18, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. DO NOT REMOVE OR ADD INSULIN FROM A FILLED CARTRIDGE AFTER LOADING ONTO THE PUMP. THIS WILL RESULT IN AN INACCURATE DISPLAY OF THE INSULIN LEVEL ON THE HOME SCREEN AND YOU COULD RUN OUT OF INSULIN BEFORE THE PUMP DETECTS AN EMPTY CARTRIDGE. THIS CAN CAUSE VERY HIGH BG, OR DIABETIC KETOACIDOSIS (DKA). 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. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 250-370 MG/DL. DURING A SYSTEMS CHECK WITH TANDEM TECHNICAL SUPPORT (CTS) IT WAS DISCOVERED THAT FIASP INSULIN WAS USED WITHIN THE CARTRIDGE AND INSULIN WAS BEING REUSED. CTS EDUCATED CUSTOMER ON INSULIN/CARTRIDGE LABELING. REPORTEDLY, THE CUSTOMER CLEARED THE ALARM AND RESUMED INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737950 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male INFUSION SET: AUTOSOFT 90 INSULIN: FIASP