BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 18231921 · Received November 29, 2023

    Report

    Report Number
    3013756811-2023-168628
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 8, 2023
    Report Date
    November 29, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000084
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A HIGH BLOOD GLUCOSE (BG) LEVEL OF 230 - 264 MG/DL. A CORRECT BOLUS VIA THE PUMP WAS ADMINISTERED TO ADDRESS BG LEVEL. TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT WAS PERFORMED AND DETERMINED THAT AIR BUBBLES WERE OBSERVED WITHIN THE INFUSION SET TUBING. CUSTOMER PRIMED THE TUBING TO ADDRESS THE ISSUE AND RESUMED INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137892 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152000084

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female