BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15329484 · Received August 31, 2022

    Report

    Report Number
    3013756811-2022-91055
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    July 31, 2022
    Report Date
    October 18, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONTROL IQ SOFTWARE DID NOT ACCURATELY ADJUST THE AMOUNT OF INSULIN DELIVERED. REPORTEDLY, THE PUMP REVERTED TO DELIVERING INSULIN BASED OFF THE PUMP PERSONAL PROFILE SETTINGS INSTEAD OF BASED OFF OF CONTROL IQ SETTINGS DESPITE CONTROL IQ BEING TURNED ON. THERE WAS NO REPORTED ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, CUSTOMER CONTINUED TO USE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2357604 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male