BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 13313809 · Received January 21, 2022

    Report

    Report Number
    3013756811-2022-07107
    Event Type
    Malfunction
    Date Received
    January 21, 2022
    Date of Event
    December 29, 2021
    Report Date
    January 21, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. 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. THE T:SLIM X2 USER GUIDE STATES: THE DISPOSABLE CARTRIDGE IS FILLED WITH UP TO 300 UNITS OF U-100 INSULIN AND ATTACHED TO THE PUMP. THE CARTRIDGE IS REPLACED EVERY 48¿72 HOURS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. REPORTEDLY, THE CUSTOMER HAD BEEN USING FIASP INSULIN WITHIN THE PUMP SUPPLIES, AND THE CARTRIDGE AND INFUSION SET HAD BEEN IN USE BEYOND LABELING. TANDEM CUSTOMER TECHNICAL SUPPORT INFORMED CUSTOMER THAT FIASP INSULIN IS OFF LABEL PER THE USER GUIDE. CUSTOMER CHANGED THE INFUSION SET TO ADDRESS OCCLUSION. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 200-320 MG/DL..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753090 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male INSULIN: FIASPINFUSION SET: AUTOSOFT 90