BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11701339 · Received April 21, 2021

    Report

    Report Number
    3013756811-2021-43642
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 25, 2021
    Report Date
    April 21, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY AND SUBSEQUENTLY SHUTDOWN. THE CUSTOMER¿S BLOOD GLUCOSE RANGED FROM 200-260 MG/DL AND CUSTOMER EXPERIENCED DIABETIC KETOACIDOSIS AND WAS ADMITTED TO THE HOSPITAL. CUSTOMER WAS ADMINISTERED INTRAVENOUS SALINE AND INSULIN, AND WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2021 WITH NO PERMANENT DAMAGE. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599602 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R