BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17548420 · Received August 15, 2023

    Report

    Report Number
    3013756811-2023-113874
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    July 25, 2023
    Report Date
    August 30, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET. CUSTOMER¿S BLOOD GLUCOSE VALUE WAS 100-114 MG/DL. REPORTEDLY, THE ALERT CLEARED, AND THE PUMP SUCCESSFULLY BEGAN CHARGING AFTER LEAVING THE PUMP PLUGGED INTO THE POWER SOURCE. THE CUSTOMER WILL CONTINUE TO USE THE CURRENT PUMP FOR INSULIN THERAPY; HOWEVER, A REPLACEMENT WAS SENT TO THE CUSTOMER TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1793756 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 67 YR Male