BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17686794 · Received September 5, 2023

    Report

    Report Number
    3013756811-2023-125283
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    August 13, 2023
    Report Date
    September 5, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613205
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED. REPORTEDLY, AN OBSTRUCTION WAS BLOCKING THE SPEAKER HOLES. AFTER REMOVING THE OBSTRUCTION FROM THE SPEAKER HOLES, THE ALARM CLEARED. CUSTOMER¿S BLOOD GLUCOSE LEVEL (BG) WAS 170-439 MG/DL. REPORTEDLY, CUSTOMER WAS ADMITTED TO THE HOSPITAL. THE CUSTOMER RECEIVED INTRAVENOUS FLUIDS OF SALINE AND INSULIN AND GLUCOSE TO ADDRESS ELEVATED BG LEVEL. REPORTEDLY, THE CUSTOMER WAS RELEASED ON (B)(6) 2023, WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE. SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT CONFIRMED THE PUMP WAS FUNCTIONING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987740 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 53 YR Female