BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13239496 · Received January 12, 2022

    Report

    Report Number
    3013756811-2022-05634
    Event Type
    Malfunction
    Date Received
    January 12, 2022
    Date of Event
    December 19, 2021
    Report Date
    January 12, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    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. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. SYSTEM CHECK WAS STARTED WITH TANDEM TECHNICAL SUPPORT (CTS) HOWEVER CUSTOMER WAS UNABLE TO COMPLETE THE CHECK. CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN DELIVERY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 202-392 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781484 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female INFUSION SET: AUTOSOFT 90INSULIN: HUMALOG