BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8748555 · Received July 1, 2019

    Report

    Report Number
    3013756811-2019-36429
    Event Type
    Injury
    Date Received
    July 1, 2019
    Date of Event
    June 1, 2019
    Report Date
    July 1, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(6)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED CONTINUOUS ELEVATED BLOOD GLUCOSE (BG 350-525 MG/DL). INFUSION SET AND CARTRIDGE WERE CHANGED MULTIPLE TIMES. CORRECTION BOLUSES WERE DELIVERED AND BASAL RATE WAS INCREASED TO ADDRESS BG. PUMP SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT (CTS) FOUND PUMP TO BE FUNCTIONING PROPERLY. CONTACT REPORTED TO HAVE CHANGED THE CUSTOMER'S PERSONAL PROFILE SETTINGS. CTS RECOMMENDED CONTACT DISCUSS EVENT WITH A HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541128 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 8 YR Other INFUSION SET: AUTOSOFT XC, INSULIN: NOVOLOG