BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17058363 · Received June 5, 2023

    Report

    Report Number
    3013756811-2023-73347
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    May 13, 2023
    Report Date
    June 5, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED. H3 : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARTRIDGE LEAKED INSULIN AT THE O-RING. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 243-244 MG/DL. THE CUSTOMER CHANGED THE CARTRIDGE TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409918 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0494777

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female INSULIN: NOVOLOG / NOVORAPID