BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 18808557 · Received February 29, 2024

    Report

    Report Number
    3013756811-2024-28362
    Event Type
    Injury
    Date Received
    February 29, 2024
    Date of Event
    December 23, 2023
    Report Date
    February 29, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. PER TANDEM USER GUIDE: ALWAYS REMOVE ALL AIR BUBBLES FROM THE CARTRIDGE BEFORE BEGINNING INSULIN DELIVERY. ENSURE THERE ARE NO AIR BUBBLES WHEN DRAWING INSULIN INTO THE FILLING SYRINGE, HOLD THE PUMP WITH THE WHITE FILL PORT POINTED UP WHEN FILLING THE TUBING, AND ENSURE THAT THERE ARE NO AIR BUBBLES IN THE TUBING WHEN FILLING. AIR IN THE SYSTEM TAKES SPACE WHERE INSULIN SHOULD BE AND CAN AFFECT INSULIN DELIVERY H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED BLOOD GLUCOSE (BG) LEVELS RANGING BETWEEN 200-473 MG/DL, DIABETIC KETOACIDOSIS, VOMITING AND SHAKING. THE CUSTOMER WENT TO THE EMERGENCY ROOM WHERE THEY WERE TREATED WITH INTRAVENOUS SALINE AND INSULIN. REPORTEDLY, CUSTOMER LEFT THE ER SAME DAY WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE. REPORTEDLY, THE BATTERY WAS DEPLETING QUICKLY AND INTERMITTENT OCCLUSION ALARMS HAD OCCURRED. CUSTOMER REPORTED USING FIASP INSULIN AND NOT PERFORMING AIR REMOVAL STEP OF THE LOAD PROCESS. TANDEM CUSTOMER CLINICAL SUPPORT INFORMED CUSTOMER THAT FIASP IS OFF LABEL PER THE USER GUIDE AND EDUCATED CUSTOMER ON PROPER AIR REMOVAL PROCEDURE. MULTIPLE ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO FOLLOW-UP WITH THE CUSTOMER ON THE REPORTED ISSUE, BUT NO RESPONSE WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452073 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 49 YR Female INSULIN: FIASP