BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 9765614 · Received February 27, 2020

    Report

    Report Number
    3013756811-2020-20104
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    February 4, 2020
    Report Date
    February 27, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007318
    PMA / PMN Number
    DEN180058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE USER GUIDE: 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. 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 THE CUSTOMER PERFORMED THE FILL TUBING SEQUENCE WHILE CONNECTED AT THE SITE. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 142-155 MG/DL. 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
    227929 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007318

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR