BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16941095 · Received May 16, 2023

    Report

    Report Number
    3013756811-2023-65826
    Event Type
    Injury
    Date Received
    May 16, 2023
    Date of Event
    April 23, 2023
    Report Date
    May 16, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. USE ERROR. 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER INADVERTENTLY PERFORMED THE LOAD SEQUENCE WHILE CONNECTED TO THE SITE. IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM (ER) WITH A BLOOD GLUCOSE (BG) LEVEL OF 120-185 MG/DL. CUSTOMER CONSUMED CARBOHYDRATES AND GLUCAGON TO ADDRESS THE BG. CUSTOMER WAS OBSERVED ONLY IN THE ER AND DISCHARGED LATER THE SAME DAY WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE. REPORTEDLY, CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. RECOMMENDATION WAS MADE TO CONSULT WITH A HEALTHCARE PROVIDER REGARDING DIABETES MANAGEMENT. 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
    2184263 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 74 YR Female INSULIN: NOVOLOG / NOVORAPID