BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 13192124 · Received January 7, 2022

    Report

    Report Number
    3013756811-2022-02987
    Event Type
    Injury
    Date Received
    January 7, 2022
    Date of Event
    December 18, 2021
    Report Date
    January 7, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007325
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE USER GUIDE: THE T:SLIM X2 WITH CIQ TECHNOLOGY USER GUIDE STATES: DO NOT USE ANY OTHER INSULIN WITH YOUR SYSTEM OTHER THAN U-100 HUMALOG OR U-100 NOVOLOG. ONLY HUMALOG AND NOVOLOG HAVE BEEN TESTED AND FOUND TO BE COMPATIBLE FOR USE IN THE SYSTEM. USE OF INSULIN WITH LESSER OR GREATER CONCENTRATION CAN RESULT IN UNDER DELIVERY OR OVER DELIVERY OF INSULIN. THIS CAN CAUSE VERY HIGH OR A VERY LOW BLOOD GLUCOSE. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. ADDITIONALLY, IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN OCCLUSION ALARM OCCURRED. REPORTEDLY, THE CUSTOMER WAS USING ADMELOG INSULIN WITHIN THE PUMP SUPPLIES. TANDEM TECHNICAL SUPPORT (CTS) INFORMED THE CUSTOMER THAT ADMELOG INSULIN IS OFF LABEL PER THE USER GUIDE. SUBSEQUENTLY, THE CUSTOMER WENT TO THE EMERGENCY ROOM (ER) DUE TO A BLOOD GLUCOSE (BG) LEVEL OF 471 MG/DL. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN WHICH RESOLVED THE ISSUES. AT THE TIME OF THE REPORT WITH CTS THERE WAS NO KNOWN PERMANENT DAMAGE AND THE CUSTOMER WAS STILL ADMITTED IN THE ER. MULTIPLE ATTEMPTS WERE MADE BY CTS TO FOLLOW-UP WITH THE CUSTOMER ON THE REPORTED ISSUE, BUT NO RESPONSE WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2517572 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000354 00853052007325

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female Required Intervention INSULIN: ADMELOG