BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11651560 · Received April 12, 2021

    Report

    Report Number
    3013756811-2021-39969
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 12, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CARTRIDGE INSTRUCTIONS FOR USE: REPLACE THE CARTRIDGE EVERY 48 HOURS IF USING HUMALOG; EVERY 72 HOURS IF USING NOVOLOG. PER TANDEM'S PUMP USER GUIDE, "DO NOT DELIVER A BOLUS UNTIL YOU HAVE REVIEWED THE CALCULATED BOLUS AMOUNT ON THE PUMP DISPLAY. IF YOU DOSE AN INSULIN AMOUNT THAT IS TOO HIGH OR TOO LOW, THIS COULD CAUSE VERY HIGH OR VERY LOW BLOOD GLUCOSE. YOU CAN ALWAYS ADJUST THE INSULIN UNITS UP OR DOWN BEFORE YOU DECIDE TO DELIVER YOUR BOLUS." NO PARTS ARE EXPECTED TO BE RETURNED FOR EVALUATION. A REVIEW OF THE DHR INDICATES THERE WERE NO NCRS OR DEVIATIONS ASSOCIATED WITH THE REPORTED PROBLEM. 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 CUSTOMER EXPERIENCED A BLOOD GLUCOSE (BG) LEVEL OF 21 MG/DL RESULTING IN A HOSPITALIZATION. CUSTOMER WAS TREATED WITH A GLUCAGON INJECTION FROM AN EMERGENCY MEDICAL TECHNICIAN AND INTRAVENOUS FLUIDS OF POTASSIUM AND DEXTROSE WERE DELIVERED WHILE HOSPITALIZED. THE CUSTOMER WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021 WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE. REPORTEDLY, THE CUSTOMER ALLEGED THAT THE CONTROL IQ PUMP SOFTWARE HAD DELIVERED A BOLUS WHEN IT WAS NOT REQUIRED RESULTING IN THE LOW BG. A SYSTEM CHECK WAS PERFORMED AND IT WAS FOUND THAT THE CUSTOMER HAD BEEN USING THE CARTRIDGE PAST LABELING AND IT WAS DETERMINED THAT THE PUMP REVERTED TO PERSONAL PROFILE SETTINGS AND WAS NO LONGER DELIVERING INSULIN BASED OFF OF CIQ SOFTWARE. THE LOW BG WAS DETERMINED TO BE CAUSED BY THE CUSTOMER MANUALLY DELIVERING A BOLUS. TANDEM TECHNICAL SUPPORT ADVISED THE CUSTOMER AGAINST USING PUMP SUPPLIES PAST LABELING. A PUMP RESET WAS PERFORMED TO ADDRESS THE EVENT AND THE CUSTOMER CONTINUED TO USE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548017 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R