BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16230177 · Received January 23, 2023

    Report

    Report Number
    3013756811-2023-10835
    Event Type
    Injury
    Date Received
    January 23, 2023
    Date of Event
    December 2, 2022
    Report Date
    January 23, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 INTERMITTENT OCCLUSION ALARMS OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IN THE RANGE OF 231-522 MG/DL. ELEVATED BLOOD GLUCOSE WAS ADDRESSED WITH A MANUAL DOSE INJECTION. THE CUSTOMER CHANGED SUPPLIES AND RESUMED INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616201 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 5397691 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other INFUSION SET: TRUSTEEL.INSULIN TYPE: NOVOLOG / NOV.