BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8759186 · Received July 3, 2019

    Report

    Report Number
    3013756811-2019-38017
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    June 13, 2019
    Report Date
    July 3, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE USER GUIDE: 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 PUMP. 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 · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED ELEVATED BLOOD GLUCOSE (BG 400-500 MG/DL) AND KETONE LEVEL WAS LARGE. CUSTOMER WAS VOMITING. HEALTHCARE PROVIDER IDENTIFIED KETONES AS DANGEROUS. AS CUSTOMER WAS YOUNG ((B)(6) YEARS OLD), CUSTOMER'S MOTHER ADMINISTERED INSULIN INJECTION TO ADDRESS BG. CONTACT REPORTED THAT ON THE FIRST DAY OF WEARING A NEW CARTRIDGE AND INFUSION SET, CUSTOMER¿S BG ELEVATE. CUSTOMER CONTINUED TO USE THE SAME CARTRIDGE AND INFUSION SET FOR THE SECOND AND THIRD DAY, AND NO ISSUES OCCURRED. PUMP SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT (CTS) AND PUMP WAS FOUND TO BE FUNCTIONING PROPERLY. CONTACT REPORTED ADMELOG WAS USED IN THE CARTRIDGE. CTS INFORMED CONTACT THAT ADMELOG WAS NOT LABELED FOR USE WITH THE PUMP. REPORTEDLY, CONTACT DISCUSSED THE TYPE OF INSULIN USED WITH A HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553759 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 9 YR Life Threatening INSULIN: ADMELOG, INFUSION SET: AUTOSOFT XC