BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T-SLIM X2 INSULIN PUMP WITH CONTROL IQ

    MDR report key: 12583299 · Received October 5, 2021

    Report

    Report Number
    MW5104410
    Event Type
    Injury
    Date Received
    October 5, 2021
    Date of Event
    October 1, 2021
    Report Date
    October 1, 2021
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    QJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TANDEM T-SLIM X2 WITH CONTROL IQ GIVES UNANNOUNCED INSULIN BOLUSES. I AM NOT ALERTED TO THE BOLUS NOR AM AWARE IT IS "ON BOARD". THERE IS NO INDICATION FROM THE PUMP THAT IT HAS JUST ADMINISTERED INSULIN. IN MY CASE I DO NOT NEED THE AUTO-CORRECT BOLUS AND IT DRIVES MY BLOOD SUGAR LOW. SEE ATTACHED SCREENSHOT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472263 TANDEM T-SLIM X2 INSULIN PUMP WITH CONTROL IQ INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER QJS TANDEM DIABETES CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR