BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13423929 · Received February 2, 2022

    Report

    Report Number
    3013756811-2022-10888
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    September 1, 2021
    Report Date
    February 2, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007257
    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 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. PER TANDEM USER GUIDE: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE. REPORTEDLY, THE CUSTOMER USES FIASP INSULIN WITHIN THE PUMP SUPPLIES AND THE CUSTOMER USED PUMP SUPPLIES BEYOND LABELING. TANDEM TECHNICAL SUPPORT EDUCATED CUSTOMER ON CARTRIDGE/INSULIN LABELING. REPORTEDLY, THE PUMP SUPPLIES WERE CHANGED TO ADDRESS THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60370 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007257

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male INSULIN: FIASPINFUSION SET: AUTOSOFT 90