BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 17059734 · Received June 5, 2023

    Report

    Report Number
    3013756811-2023-77693
    Event Type
    Injury
    Date Received
    June 5, 2023
    Date of Event
    May 9, 2023
    Report Date
    June 5, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007301
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED THE PUMP SUPPLIES AND SUCCESSFULLY RESUMED INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 250-545 MG/DL. ELEVATED BLOOD GLUCOSE LEVELS WERE ADDRESSED BY MANUAL INSULIN INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2293404 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 W0793577 00853052007301

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female INFUSION SET: TRUSTEELINSULIN TYPE: NOVOLOG/ NOVO