BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16785919 · Received April 21, 2023

    Report

    Report Number
    3013756811-2023-53529
    Event Type
    Injury
    Date Received
    April 21, 2023
    Date of Event
    March 31, 2023
    Report Date
    April 21, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL OF 40 MG/DL. SUSPECTED CAUSE WAS DUE TO CUSTOMERS CORRECTION FACTOR NEEDING ADJUSTMENTS. REPORTEDLY, CUSTOMER RECEIVED ASSISTANCE FROM THEIR MANAGER BY PROVIDING APPLE, PEANUT BUTTER, AND MOUNTAIN DEW TO ADDRESS BG LEVEL. REPORTEDLY, TANDEM TECHNICAL SUPPORT ASSISTED CUSTOMER IN MAKING SETTINGS ADJUSTMENTS TO BETTER FIT THEIR NEEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791775 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 40 YR Female