BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16242603 · Received January 25, 2023

    Report

    Report Number
    3013756811-2023-11376
    Event Type
    Injury
    Date Received
    January 25, 2023
    Date of Event
    January 3, 2023
    Report Date
    January 25, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000077
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED IN THE INTENSIVE CARE UNIT DUE TO A BLOOD GLUCOSE (BG) LEVEL OF 800 - 900 MG/DL AND HIGH KETONES WHICH WERE IDENTIFIED AS DANGEROUS BY A HEALTHCARE PROFESSIONAL. REPORTEDLY THE CUSTOMER ADDRESSED BG WITH A CORRECTION BOLUS VIA THE PUMP AND WAS TREATED INTRAVENOUSLY WITH FLUIDS OF SALINE AND INSULIN AT THE HOSPITAL. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, IT WAS DISCOVERED THAT AN UNDEFINED CARTRIDGE ALARM OCCURRED. MULTIPLE ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO FOLLOW-UP WITH THE CUSTOMER ON THE REPORTED ISSUE, BUT NO RESPONSE WAS RECEIVED, THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786117 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152000077

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female Required Intervention| H| L