BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12641672 · Received October 15, 2021

    Report

    Report Number
    3013756811-2021-111307
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    September 30, 2021
    Report Date
    October 15, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007318
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4 (LOT NUMBER).

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE PUMP USER GUIDE STATES: 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. THIS CAN CAUSE SERIOUS INJURY OR DEATH FROM VERY LOW BLOOD GLUCOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 300 UNITS OF INSULIN DURING THE LOAD SEQUENCE. A NEW CARTRIDGE WAS LOADED TO RESOLVE THE ISSUE. ADDITIONALLY, IT WAS REPORTED THAT THE CUSTOMER INADVERTENTLY PERFORMED THE LOAD FILL TUBING SEQUENCE WHILE CONNECTED TO THE SITE. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER TO NOT BE CONNECTED TO THE PUMP DURING THE FILL TUBING PROCESS. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 140-159 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536999 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 60253949 00853052007318

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR