BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16210218 · Received January 19, 2023

    Report

    Report Number
    3013756811-2023-09474
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 30, 2022
    Report Date
    January 19, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613731
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED THE PUMP SUPPLIES AND SUCCESSFULLY RESUMED INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 200-385 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95419 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 W0600865 00850006613731

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female INFUSION SET: AUTOSOFT XCINSULIN: HUMALOG