BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16004412 · Received December 19, 2022

    Report

    Report Number
    3013756811-2022-143676
    Event Type
    Injury
    Date Received
    December 19, 2022
    Date of Event
    December 2, 2022
    Report Date
    December 19, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 LEVEL OF 36 MG/DL. THE CUSTOMER CONSUMED 3 BOXES OF JUICE TO ADDRESS THE LOW BG. THE CAUSE OF THE LOW BG WAS UNKNOWN. REPORTEDLY, THE REPORTED ISSUE RESOLVED AND BG LEVEL INCREASED TO 162-163 MG/DL. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227223 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other INSULIN TYPE: HUMALOGINFUSION SET: AUTOSOFT 30