BEUDAMED
    FDA Adverse Event Death Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16521188 · Received March 10, 2023

    Report

    Report Number
    3013756811-2023-28849
    Event Type
    Death
    Date Received
    March 10, 2023
    Date of Event
    December 21, 2022
    Report Date
    March 10, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. 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."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL AND WAS INCOHERENT. CAUSE OF ELEVATED BG WAS UNKNOWN. REPORTEDLY, THE PUMP BATTERY FULLY DEPLETED AND SUBSEQUENTLY SHUT DOWN DUE TO CUSTOMER NOT CHARGING THE PUMP. THE CUSTOMER¿S SPOUSE DIALED 911, AND PARAMEDICS PERFORMED A FINGERSTICK WHICH INDICATED CUSTOMER¿S BG LEVEL WAS OVER 1,000 MG/DL. CUSTOMER WAS TAKEN VIA AMBULANCE TO THE EMERGENCY ROOM AND SUBSEQUENTLY ADMITTED TO THE HOSPITAL WHERE THEY WERE PLACED IN A MEDICALLY INDUCED COMA. REPORTEDLY, THE CUSTOMER PASSED AWAY ON (B)(6) 2022, TWO DAYS AFTER THE INITIAL EVENT. MULTIPLE FOLLOW-UP ATTEMPTS WERE MADE BUT NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. THE PUMP WAS NOT UPLOADED TO T:CONNECT, THEREFORE THE PUMP LOG COULD NOT BE INVESTIGATED. IT IS NOT CURRENTLY KNOWN THE EXTENT TO WHICH THE DEVICE SHUTTING OFF DUE TO LOW POWER WAS RELEVANT TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148839 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Hospitalization| R| D