BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 18095016 · Received November 8, 2023

    Report

    Report Number
    3013756811-2023-158564
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 15, 2023
    Report Date
    December 21, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO CARTRIDGE WAS RECEIVED FOR INVESTIGATION THEREFORE NO EVALUATION COULD BE PERFORMED. H6: REMOVE 11, 3233, AND 4118; H10; D9 H6: REMOVE 11, 3233, AND 4118; H10; D9.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MULTIPLE CARTRIDGES WERE LEAKING FROM THE SEPTUM. CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788427 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 11 YR Female