BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15847431 · Received November 22, 2022

    Report

    Report Number
    3013756811-2022-129499
    Event Type
    Injury
    Date Received
    November 22, 2022
    Date of Event
    October 29, 2022
    Report Date
    November 22, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007325
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP USER GUIDE STATES, "TANDEM DIABETES CARE, INC. RECOMMENDS PERIODICALLY CHECKING THE BATTERY LEVEL INDICATOR, CHARGING THE PUMP FOR A SHORT PERIOD OF TIME EVERY DAY (10 TO 15 MINUTES), AND ALSO AVOIDING FREQUENT FULL DISCHARGES." 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 BLOOD GLUCOSE (BG) LEVEL OF 750 MG/DL, BLURRY VISION, AND A HIGH KETONE LEVEL IDENTIFIED AS DANGEROUS BY HEALTHCARE PROFESSIONAL. REPORTEDLY, THE PUMP BATTERY FULLY DEPLETED AND THE PUMP SHUT OFF DUE TO THE CUSTOMER NOT CHARGING THE PUMP. THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED IN THE INTENSIVE CARE UNIT. BG WAS TREATED WITH INTRAVENOUS INSULIN AND SALINE. REPORTEDLY, THE CUSTOMER WAS RELEASED ON 10/30/2022 WITH THE ISSUE RESOLVED; HOWEVER, CUSTOMER INDICATED IT WAS POSSIBLE PERMANENT VISION AND KIDNEY ISSUES WERE SUSTAINED. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368016 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00853052007325

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male Hospitalization| R| L INSULIN: HUMALOG