BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15610382 · Received October 14, 2022

    Report

    Report Number
    3013756811-2022-113994
    Event Type
    Injury
    Date Received
    October 14, 2022
    Date of Event
    March 23, 2022
    Report Date
    October 14, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 INTERMITTENT OCCLUSIONS ALARMS OCCURRED. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL OF AROUND 600-700 MG/DL WITH HIGH LEVELS OF KETONES. KETONE LEVELS WERE IDENTIFIED AS LIFE THREATENING BY HEALTH CARE PROVIDER. ELEVATED BLOOD GLUCOSE LEVELS BY MANUAL INSULIN INJECTION AND CHANGING PUMP SUPPLIES. CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT. BG WAS TREATED WITH INTRAVENOUS FLUIDS OF INSULIN AND SALINE, "A PAIN MED AND GI MEDS" (CUSTOMER DID NOT IDENTIFY SPECIFIC MEDICINES). REPORTEDLY, THE CUSTOMER WAS RELEASED AFTER THREE DAYS WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2666356 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention| H| L INSULIN: NOVOLOG/ NOVORAPID