BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12639390 · Received October 15, 2021

    Report

    Report Number
    3013756811-2021-112288
    Event Type
    Injury
    Date Received
    October 15, 2021
    Date of Event
    September 23, 2021
    Report Date
    October 15, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER ALLOWED THE PUMP BATTERY TO FULLY DEPLETE DUE TO NOT CHARGING THE BATTERY AND THE PUMP SUBSEQUENTLY SHUT OFF. THE CUSTOMER EXPERIENCED A "HIGH" BLOOD GLUCOSE (BG) LEVEL (SPECIFIC BG VALUE WAS NOT PROVIDED). CUSTOMER DELIVERED A BOLUS VIA THE PUMP TO ADDRESS BG. ADDITIONALLY, IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BG OF 82 MG/DL; CAUSE WAS UNKNOWN. CUSTOMER REQUIRED ASSISTANCE FROM EMERGENCY MEDICAL TECHNICIANS TO CONSUME PEANUT BUTTER AND A HONEY SANDWICH TO ADDRESS BG. RECOMMENDATION WAS MADE TO DISCUSS DIABETES MANAGEMENT WITH A HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537780 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 62 YR Required Intervention