BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 18357512 · Received December 19, 2023

    Report

    Report Number
    3013756811-2023-176657
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    November 29, 2023
    Report Date
    January 26, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP WAS WARM TO THE TOUCH DESPITE BEING IN ROOM-TEMPERATURE CONDITIONS. REPORTEDLY, THE PUMP WAS CHARGING DURING THE EVENT. ADDITIONALLY, IT WAS REPORTED THAT MULTIPLE MALFUNCTION ALARMS OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE WAS 120-235 MG/DL. CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152265 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 21 YR Female