BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16207323 · Received January 19, 2023

    Report

    Report Number
    3013756811-2023-07957
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 20, 2022
    Report Date
    March 29, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION: HOWEVER, DEVICE EVALUTAION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION. PER TANDEM USER GUIDE: CHANGE YOUR INFUSION SET EVERY 48¿72 HOURS AS RECOMMENDED BY YOUR HEALTHCARE PROVIDER. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER DELIVERED 2 AIR BOLUS'S AND SUCCESSFULLY RESUMED INSULIN THERAPY. REPORTEDLY, THE CUSTOMER IS REMOVING CARTRIDGE AIR BUBBLES WITH AN EMPTY SYRINGE SOMETIMES, AND WEARS THE INFUSION SET FOR 3-4 DAYS. CLINICAL SUPPORT ADVISED CUSTOMER THAT REMOVING CARTRIDGE AIR BUBBLES WITH AN EMPTY SYRINGE SOMETIMES, AND WEARING THE INFUSION SET FOR 3-4 DAYS, IS OFF LABEL PER THE TANDEM USER GUIDE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 190-218 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166166 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 61 YR Female INFUSION SET: TRUSTEELINSULIN: NOVOLOG/ NOVO RAPI