BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17096963 · Received June 9, 2023

    Report

    Report Number
    3013756811-2023-76494
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    May 19, 2023
    Report Date
    June 9, 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 AN ALTITUDE ALARM OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. REPORTEDLY A NEW CARTRIDGE WAS LOADED, AND INSULIN DELIVERY WAS RESUMED. ADDITIONALLY, IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. CUSTOMER PERFORMED A SUPPLY CHANGE RESOLVING THE OCCLUSION. THE CUSTOMER'S BLOOD GLUCOSE WAS 123-179 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2135030 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 48 YR Female INSULIN: HUMALOGINFUSION SET: AUTOSOFT 90.