BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16573244 · Received March 20, 2023

    Report

    Report Number
    3013756811-2023-36239
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    February 23, 2023
    Report Date
    May 12, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000077
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 0

    WAKE BUTTON WAS VERIFIED. UNEXPECTED SHUTDOWN ISSUES THE FAILURE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED ISSUE WAS VERIFIED, HOWEVER, NO FAILURE WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP SHUT OFF UNEXPECTEDLY. ADDITIONALLY, IT WAS REPORTED THAT THE WAKE BUTTON WAS UNRESPONSIVE. PUMP DISPLAY TURNED ON WHEN PLUGGED INTO A POWER SOURCE. CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS 131 ¿ 189 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007533 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152000077

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male