BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 18543175 · Received January 19, 2024

    Report

    Report Number
    3013756811-2024-15621
    Event Type
    Injury
    Date Received
    January 19, 2024
    Date of Event
    December 18, 2023
    Report Date
    February 26, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. THE CUSTOMER WENT TO THE EMERGENCY ROOM AND SUBSEQUENTLY HOSPITALIZED IN THE INTENSIVE CARE UNIT (ICU) WITH A BLOOD GLUCOSE LEVEL OF OVER 600 MG/DL WITH HIGH KETONES THAT WERE IDENTIFIED AS DANGEROUS MY A HEALTHCARE PROVIDER. THE CUSTOMER ATTEMPTED TO SELF-TREAT WITH A SUPPLY CHANGE BUT WAS TREATED INTRAVENOUSLY WITH FLUIDS OF SALINE AND INSULIN IN THE ICU. THE CUSTOMER WAS RELEASED ON (B)(6) 2024 WITH ISSUE RESOLVED AND NO PERMANENT DAMAGE. THE CUSTOMER REVERTED TO MANUAL DOSE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478662 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 25 YR Female INFUSION SET: AUTOSOFT XC INSULIN TYPE: HUMALOG