BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12464961 · Received September 13, 2021

    Report

    Report Number
    3013756811-2021-97456
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    August 21, 2021
    Report Date
    September 13, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM USER GUIDE: CHANGE YOUR INFUSION SET EVERY 48¿72 HOURS AS RECOMMENDED BY YOUR HEALTHCARE PROVIDER. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE. REPORTEDLY, THE CUSTOMER IS USING THE INFUSION SET FOR 3 DAYS. CLINICAL SUPPORT INFORMED THE CUSTOMER THAT USING TRUSTEEL INFUSION SET FOR 3 DAY¿S IS OFF LABEL PER THE TANDEM USER GUIDE. CUSTOMERS BLOOD GLUCOSE WAS 210-300 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362197 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 54 YR