BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15762502 · Received November 9, 2022

    Report

    Report Number
    3013756811-2022-122978
    Event Type
    Injury
    Date Received
    November 9, 2022
    Date of Event
    October 18, 2022
    Report Date
    November 9, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL OF 051-107 MG/DL. SUSPECTED CAUSE WAS DUE TO THE CUSTOMER¿S SETTINGS REQUIRING ADJUSTMENTS. CUSTOMER CONSUMED CARBOHYDRATE TO ADDRESS LOW BG. TANDEM TECHNICAL SUPPORT ADVISED THE CUSTOMER TO CONSULT THEIR HEALTHCARE PROVIDER TO REVIEW SETTINGS AND MAKE ADJUSTMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2951585 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other