BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12851583 · Received November 22, 2021

    Report

    Report Number
    3013756811-2021-124952
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    November 6, 2021
    Report Date
    November 22, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 OCCLUSION ALARMS OCCURRED. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS TO ADDRESS THE ISSUE. CUSTOMER'S BLOOD GLUCOSE RANGED BETWEEN 231-318 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749071 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 17 YR Male INFUSION SET: AUTOSOFT XCINSULIN: NOVOLOG