BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15191771 · Received August 9, 2022

    Report

    Report Number
    3013756811-2022-86853
    Event Type
    Malfunction
    Date Received
    August 9, 2022
    Date of Event
    July 17, 2022
    Report Date
    July 22, 2022
    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. PER TANDEM USER GUIDE: CHANGE YOUR INFUSION SET EVERY 48¿72 HOURS AS RECOMMENDED BY YOUR HEALTHCARE PROVIDER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. CUSTOMER CHANGED THE PUMP SUPPLIES AND SUCCESSFULLY RESUMED INSULIN THERAPY. REPORTEDLY, THE CUSTOMER WAS WEARING THE INFUSION SET FOR 4.5 DAYS. TANDEM CLINICAL SUPPORT INFORMED CUSTOMER THAT WEARING THE PUMP SUPPLIES FOR 4.5 DAYS IS OFF LABEL PER THE TANDEM USER GUIDE.CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 101-104 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2248376 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 51 YR Male INFUSION SET: TRUSTEEL, AUTOSOFT 90INSULIN: NOVOL