BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16584481 · Received March 21, 2023

    Report

    Report Number
    3013756811-2023-34714
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    February 5, 2023
    Report Date
    March 21, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000077
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 LOSSES OF OUT OF RANGE ISSUES OCCURRED BETWEEN THE TRANSMITTER AND PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS REPORTED BETWEEN 120-215 MG/DL. REPORTEDLY, THE PUMP AND TRANSMITTER REGAINED CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24229 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152000077

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female