BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16732552 · Received April 13, 2023

    Report

    Report Number
    3013756811-2023-52207
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Date of Event
    March 3, 2023
    Report Date
    April 13, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. PER TANDEM USER GUIDE: CHANGE YOUR CARTRIDGE EVERY 48¿72 HOURS AS RECOMMENDED BY YOUR HEALTHCARE PROVIDER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CLEARED THE ALARM AND RESUMED INSULIN THERAPY AND CUSTOMER CHANGED THE PUMP SUPPLIES AND SUCCESSFULLY RESUMED INSULIN THERAPY. REPORTEDLY, THE CUSTOMER IS WEARING THE PUMP SUPPLIES FOR 3 DAYS. CLINICAL SUPPORT INFORMED CUSTOMER THAT WEARING THE PUMP SUPPLIES FOR 3 DAYS, IS OFF LABEL PER THE USER GUIDE. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 240-280 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479152 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0720007 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female INFUSION SET: TRUSTEEL, AUTOSOFT 90INSULIN TYPE: