BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13892272 · Received March 24, 2022

    Report

    Report Number
    3013756811-2022-30428
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    March 8, 2022
    Report Date
    March 8, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. PER TANDEM'S USER GUIDE: THE SINGLE-USE DISPOSABLE CARTRIDGE CAN HOLD UP TO 300 UNITS (3.0 ML) OF INSULIN. DEVICE NOT RETURNED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARTRIDGE WAS LEAKING FROM THE O-RING. REPORTEDLY, THE CUSTOMER OVERFILLED THE CARTRIDGE AND THE CARTRIDGE BURST. CUSTOMER LOADED A NEW CARTRIDGE TO ADDRESS THE ISSUE. CUSTOMER'S BLOOD GLUCOSE WAS 180-270 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304667 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0302211 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female