BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12532258 · Received September 27, 2021

    Report

    Report Number
    3013756811-2021-105881
    Event Type
    Injury
    Date Received
    September 27, 2021
    Date of Event
    September 11, 2021
    Report Date
    September 27, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED DIFFICULTY CHARGING THE PUMP WITH THE USB CABLE. REPORTEDLY, THE CUSTOMER WAS ABLE TO CHARGE THE PUMP WITH AN ALTERNATE CABLE. IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL RANGING FROM 200-502 MG/DL. REPORTEDLY, THE CUSTOMER ADMINISTERED A MANUAL INJECTION TO ADDRESS ELEVATED BG LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431840 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other