BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16702868 · Received April 7, 2023

    Report

    Report Number
    3013756811-2023-50947
    Event Type
    Injury
    Date Received
    April 7, 2023
    Date of Event
    March 7, 2023
    Report Date
    April 7, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY WITH MULTIPLE CARTRIDGES. CUSTOMER LOADED A NEW CARTRIDGE TO RESOLVE THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 240-700 MG/DL. REPORTEDLY, CUSTOMER CHANGED THE CARTRIDGE AND DELIVERED A CORRECTION BOLUS VIA THE PUMP TO ADDRESS BG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1752789 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0459556 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male