BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11047848 · Received December 21, 2020

    Report

    Report Number
    3013756811-2020-149603
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    December 10, 2020
    Report Date
    December 21, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613205
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE TANDEM USER GUIDE: CHECK YOUR PUMP¿S PERSONAL SETTINGS REGULARLY TO ENSURE THEY ARE CORRECT. INCORRECT SETTINGS CAN RESULT IN OVER DELIVERY OR UNDER DELIVERY OF INSULIN. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP CORRECTION FACTOR SETTING HAD BEEN ENTERED INCORRECTLY. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, SETTING WAS CORRECTED AND INSULIN THERAPY SUCCESSFULLY RESUMED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 223 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508654 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613205

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR