BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11202841 · Received January 20, 2021

    Report

    Report Number
    3013756811-2021-03116
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    December 31, 2020
    Report Date
    January 20, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE MINIMUM FILL NOTIFICATIONS OCCURRED AFTER FILLING THE CARTRIDGE WITH APPROXIMATELY 150 UNITS OF INSULIN. IN ADDITION, IT WAS REPORTED THAT THE CARTRIDGE WAS LEAKING AT THE SEPTUM. ADDITIONALLY, IT WAS REPORTED THAT RESISTANCE WAS FELT WHEN FILLING THE CARTRIDGE DURING THE LOAD SEQUENCE. THE CUSTOMER ULTIMATELY SUCCESSFULLY FILLED AND LOADED THE CARTRIDGE ONTO THE PUMP. IN ADDITION, THAT INSULIN DRIPS WERE NOT OBSERVED TO BE EXITING THE INFUSION SET TUBING DURING THE LOAD FILL TUBING PROCESS. REPORTEDLY, THE PUMP SUPPLIES WERE CHANGED TO ADDRESS THE ISSUE. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 180-197 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98605 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR