BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16498183 · Received March 7, 2023

    Report

    Report Number
    3013756811-2023-27722
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 13, 2023
    Report Date
    March 7, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED. PER THE USER GUIDE: WARNING - NEVER FILL YOUR TUBING WHILE YOUR INFUSION SET IS CONNECTED TO YOUR BODY. ALWAYS ENSURE THAT THE INFUSION SET IS DISCONNECTED FROM YOUR BODY BEFORE FILLING THE TUBING. FAILURE TO DISCONNECT YOUR INFUSION SET FROM YOUR BODY BEFORE FILLING THE TUBING CAN RESULT IN OVER DELIVERY OF INSULIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARTRIDGE WAS LEAKING FROM THE O-RING. CUSTOMER LOADED A NEW CARTRIDGE TO ADDRESS THE ISSUE. ADDITIONALLY, IT WAS REPORTED THAT THE CUSTOMER INADVERTENTLY PERFORMED THE LOAD SEQUENCE WHILE CONNECTED TO THE SITE. THE CUSTOMER'S BLOOD GLUCOSE WAS IN 250-286 MG/DL RANGE. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER TO NOT BE CONNECTED TO THE PUMP DURING THE FILL TUBING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86403 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male