BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17034407 · Received May 31, 2023

    Report

    Report Number
    3013756811-2023-75182
    Event Type
    Injury
    Date Received
    May 31, 2023
    Date of Event
    May 9, 2023
    Report Date
    May 31, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 INTERMITTENT ELEVATED BLOOD GLUCOSE (BG ) LEVELS RANGING BETWEEN 233-567 MG/DL. CAUSE WAS UNKNOWN ON (B)(6) 2023. TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT WAS PERFORMED ON (B)(6) 2023 AND DETERMINED INSULIN WAS NOT BEING DELIVERED FROM THE CARTRIDGE. CUSTOMER ADMINISTERED A CORRECTION INJECTION AS WELL AS PERFORMED A SUPPLY CHANGE TO ADDRESS THE BG. INSULIN THERAPY WAS SUCCESSFULLY RESUMED AFTER THE SUPPLY CHANGE. RECOMMENDATION WAS MADE TO CONSULT A HEALTHCARE PROVIDER IN REGARDS TO DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837840 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female INSULIN: HUMALOG