BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13336785 · Received January 24, 2022

    Report

    Report Number
    3013756811-2022-04036
    Event Type
    Injury
    Date Received
    January 24, 2022
    Date of Event
    December 31, 2021
    Report Date
    January 1, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION RESULTS: THE INVESTIGATION HAS BEEN COMPLETED. FUNCTIONAL/DUPLICATION TESTING WAS PERFORMED, AND NO FAILURE WAS IDENTIFIED RELATED TO THE REPORTED ISSUE. THE INFORMATION WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL OF 39 MG/DL RESULTING IN THE CUSTOMER VISITING THE EMERGENCY ROOM (ER). BG CAUSE WAS NOT KNOWN. CUSTOMER CONSUMED CARBOHYDRATES TO ATTEMPT TO SELF ADDRESS BG. DURING ER VISIT THE CUSTOMER WAS TREATED WITH GLUCOSE TABLETS, FOOD, AND UNDERWENT LAB WORK WHICH REPORTEDLY RESOLVED THE ISSUES. SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT CONFIRMED THAT THE PUMP AND RELATED SUPPLIES WERE FUNCTIONING AS INTENDED. THE CUSTOMER WAS RELEASED FROM THE ER ON (B)(6) 2022 WITH NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559352 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention