BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16283581 · Received February 2, 2023

    Report

    Report Number
    3013756811-2023-13348
    Event Type
    Injury
    Date Received
    February 2, 2023
    Date of Event
    January 9, 2023
    Report Date
    March 21, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION.

    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 WAS TAKEN TO THE HOSPITAL BY PARAMEDICS DUE TO A BLOOD GLUCOSE (BG) LEVEL OF 54 MG/DL, LOSS OF CONSCIOUSNESS AND CONVULSIONS. PRIOR TO THE HOSPITALIZATION, THE CUSTOMER CONSUMED CARBOHYDRATES IN ATTEMPT TO RESOLVE THE REPORTED ISSUE. CUSTOMER WAS TREATED WITH INTRAVENOUS SALINE AND INSULIN WHILE IN THE HOSPITAL, AND WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2023 WITH NO PERMANENT DAMAGE. UPON BEING RELEASED FROM THE HOSPITAL THE CUSTOMER WAS FEELING "OK", TIRED AND SORE. THE CAUSE FOR THE REPORTED ISSUE WAS REPORTEDLY DUE TO THE CONTROL-IQ ALGORITHM INCREASING BASAL DELIVERY IN RESPONSE TO THE CONTINUOUS GLUCOSE MONITOR (CGM) SENSOR READING; HOWEVER, THE CGM SENSOR READING WAS INACCURATE. REPORTEDLY, THE CGM BG READING WAS 54 MG/DL AND THE BG METER READING FROM 162-163 MG/DL. THE CUSTOMER ACKNOWLEDGED THE PUMP FUNCTIONED AS INTENDED AND DECLINED TO PERFORM A SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380899 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 41 YR Male Required Intervention| H