BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9318527 · Received November 13, 2019

    Report

    Report Number
    3013756811-2019-77855
    Event Type
    Injury
    Date Received
    November 13, 2019
    Date of Event
    October 12, 2019
    Report Date
    November 13, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM¿S T:SLIM X2 G6 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 SYSTEM." NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE (BG) RANGED FROM 200-556 MG/DL. A CORRECTION BOLUS VIA THE PUMP WAS DELIVERED TO ADDRESS BG. REPORTEDLY, THE PUMP SUPPLIES WERE CHANGED TO ADDRESS THE ISSUE. ADDITIONALLY, CUSTOMER WAS USING APIDRA INSULIN. TANDEM TECHNICAL SUPPORT EDUCATED CUSTOMER REGARDING CARTRIDGE/INSULIN LABELING. REPORTEDLY, CUSTOMER CONSULTED A HEALTHCARE PROVIDER REGARDING ALTERNATE INSULIN TYPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111793 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 26 YR Other