BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12732079 · Received November 1, 2021

    Report

    Report Number
    3013756811-2021-115590
    Event Type
    Injury
    Date Received
    November 1, 2021
    Date of Event
    October 9, 2021
    Report Date
    November 1, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. REPORTEDLY, CUSTOMER IS USING INSULIN AND INFUSION SET FOR LONGER THAN RECOMMEND BY HEALTH CARE PROFESSIONAL. TANDEM CUSTOMER TECHNICAL SUPPORT INFORMED CUSTOMER THAT USING INSULIN AND INFUSION SET LONGER THAN RECOMMENDED IS OFF LABEL PER THE USER GUIDE. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE. CUSTOMERS BLOOD GLUCOSE (BG) WAS 211 - 387 MG/DL. ULTIMATELY, CUSTOMER WENT TO THE EMERGENCY ROOM FOR ELEVATED BG. CUSTOMER WAS GIVEN INTRAVENOUS FLUIDS OF SALINE AND INSULIN. CUSTOMER WAS RELEASED SAME DAY WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628893 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 65 YR Required Intervention