BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM X2 SLIM CONTROL IQ

    MDR report key: 11093608 · Received December 29, 2020

    Report

    Report Number
    MW5098561
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 15, 2020
    Report Date
    December 25, 2020
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    QJI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM TYPE 1 DIABETIC WEAR TANDEM X2 SLIM CONTROL IQ PUMP, ON MY FLIGHT FORM (B)(6) TO (B)(6) PUMP STOPPED INSULIN DELIVERIES AND FLASHED ALTITUDE ERROR. ON THEIR WEBSITE THERE IS NO WARNING OR WHAT TO DO IF YOU FLY. CALLED UP TANDEM AND CAME TO KNOW BECAUSE OF PRESSURE THIS HAPPENED AND THE 6 SMALL HOLES IN THE BACK GOT BLOCKED. THEY SHOULD HAVE THIS WARNING IN RED AND HOW TO PREVENT IT FROM HAPPENING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549912 TANDEM X2 SLIM CONTROL IQ INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER QJI TANDEM DIABETES CARE, INC. X2 SLIM

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other