BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17180939 · Received June 22, 2023

    Report

    Report Number
    3013756811-2023-86923
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    June 1, 2023
    Report Date
    June 22, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000077
    PMA / PMN Number
    K201214
    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 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 AIR BUBBLES WERE OBSERVED WITHIN THE INFUSION SET TUBING. REPORTEDLY THE CUSTOMER WAS NOT PERFORMING THE AIR REMOVAL STEP. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER THAT NOT PERFORMING THE AIR REMOVAL STEP IS OFF LABEL PER THE TANDEM USER GUIDE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 180-340 MG/DL. CUSTOMER PRIMED THE TUBING TO ADDRESS THE ISSUE AND RESUMED INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133986 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 60414463 00389152000077

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male