BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

    MDR report key: 19404601 · Received May 28, 2024

    Report

    Report Number
    3013756811-2024-94406
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    May 6, 2024
    Report Date
    May 28, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000107
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THE PUMP USER GUIDE CAUTIONS THAT INSULIN SHOULD BE AT ROOM TEMPERATURE BEFORE USE OR AIR BUBBLES COULD FORM IN THE CARTRIDGE. THE PUMP USER GUIDE INSTRUCTS THE USER TO REMOVE ANY RESIDUAL AIR FROM THE CARTRIDGE. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. REPORTEDLY, THE CUSTOMER WAS USING COLD FIASP INSULIN WITH THE PUMP, AND WAS NOT PERFORMING THE AIR REMOVAL STEP OF THE LOAD PROCESS PROPERLY. TANDEM CUSTOMER TECHNICAL SUPPORT INFORMED CUSTOMER OF PROPER INSULIN/SUPPLY USAGE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664030 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00389152000107

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male INSULIN: FIASP.