BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13078712 · Received December 23, 2021

    Report

    Report Number
    3013756811-2021-143791
    Event Type
    Malfunction
    Date Received
    December 23, 2021
    Date of Event
    December 15, 2021
    Report Date
    December 23, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. PER TANDEM USER GUIDE: ONLY USE U-100 HUMALOG OR U-100 NOVOLOG WITH YOUR PUMP. ONLY U-100 HUMALOG AND NOVOLOG HAVE BEEN TESTED AND FOUND TO BE COMPATIBLE FOR USE IN THE PUMP. USE OF INSULIN WITH LESSER OR GREATER CONCENTRATION CAN RESULT IN UNDER DELIVERY OR OVER DELIVERY OF INSULIN. THIS CAN CAUSE HYPOGLYCEMIA (LOW BG) OR HYPERGLYCEMIA (HIGH BG) EVENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. SYSTEM CHECK WAS STARTED WITH TANDEM TECHNICAL SUPPORT (CTS) HOWEVER CUSTOMER DECLINED TROUBLESHOOTING. REPORTEDLY THE CUSTOMER IS USING FIASP INSULIN. TANDEM CUSTOMER TECHNICAL SUPPORT (CTS) INFORMED CUSTOMER THAT FIASP IS OFF LABEL PER THE USER GUIDE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 193 -216 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977932 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 57 YR Female INSULIN: FIASPINFUSION SET: TRUSTEEL