BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13361380 · Received January 26, 2022

    Report

    Report Number
    3013756811-2022-04855
    Event Type
    Injury
    Date Received
    January 26, 2022
    Date of Event
    December 31, 2021
    Report Date
    January 26, 2022
    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
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS CRACKED AND UNRESPONSIVE. AS A RESULT, CUSTOMER¿S BLOOD GLUCOSE LEVEL INCREASED TO 800-900 MG/DL. CUSTOMER ATTEMPTED TO ADDRESS THEIR BG LEVEL WITH MANUAL DOSES OF INSULIN BUT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER) AND SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT (ICU) ON (B)(6)2022. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN AND RELEASED FROM THE ICU ON 1/3/2022 WITH NO REPORTED PERMANENT DAMAGE AND THE ISSUE RESOLVED. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD IN INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114837 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 12 YR Female Hospitalization| R