BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15718166 · Received November 2, 2022

    Report

    Report Number
    3013756811-2022-123387
    Event Type
    Malfunction
    Date Received
    November 2, 2022
    Date of Event
    June 1, 2022
    Report Date
    November 2, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    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 SUBMIT. PER THE TANDEM USER GUIDE: THE T:SLIM X2 WITH CIQ TECHNOLOGY USER GUIDE STATES: DO NOT USE ANY OTHER INSULIN WITH YOUR SYSTEM OTHER THAN U-100 HUMALOG OR U-100 NOVOLOG. ONLY HUMALOG AND NOVOLOG HAVE BEEN TESTED AND FOUND TO BE COMPATIBLE FOR USE IN THE SYSTEM. USE OF INSULIN WITH LESSER OR GREATER CONCENTRATION CAN RESULT IN UNDER DELIVERY OR OVER DELIVERY OF INSULIN. THIS CAN CAUSE VERY HIGH OR A VERY LOW BLOOD GLUCOSE. CHANGE YOUR CARTRIDGE EVERY 48¿72 HOURS AS RECOMMENDED BY YOUR HEALTHCARE PROVIDER. WASH YOUR HANDS WITH ANTI-BACTERIAL SOAP BEFORE HANDLING THE INFUSION SET AND THOROUGHLY CLEAN THE INSERTION SITE ON YOUR BODY TO AVOID INFECTION. CONTACT YOUR HEALTHCARE PROVIDER IF YOU HAVE SYMPTOMS OF INFECTION AT YOUR INSULIN INFUSION SITE. THE PUMP USER GUIDE CAUTIONS THAT INSULIN SHOULD BE AT ROOM TEMPERATURE BEFORE USE OR AIR BUBBLES COULD FORM IN THE CARTRIDGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. REPORTEDLY, THE CUSTOMER USED ADMELOG INSULIN WITHIN THE CARTRIDGE. ADDITIONALLY, THE CUSTOMER WAS USING COLD INSULIN AND USING CARTRIDGES BEYOND LABELING. TANDEM TECHNICAL SUPPORT EDUCATED CUSTOMER ON PROPER INSULIN/SUPPLY USAGE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 89 MG/DL. REPORTEDLY, THE CUSTOMER CLEARED THE ALARMS AND CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2874160 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male INSULIN: ADMELOG INFUSION SET: AUTOSOFT XC