BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16114835 · Received January 6, 2023

    Report

    Report Number
    3013756811-2023-03858
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    December 15, 2022
    Report Date
    February 1, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 A CARTRIDGE ALARM 1 OCCURRED DURING BASAL DELIVERIES. A NEW CARTRIDGE WAS SUCCESSFULLY LOADED TO ADDRESS THE EVENT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 150 - 270 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565758 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0422705 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female