BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16713355 · Received April 11, 2023

    Report

    Report Number
    3013756811-2023-49912
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 21, 2023
    Report Date
    September 5, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CARTRIDGE ALARM 05 OCCURRED. REPORTEDLY, THE CUSTOMER HAD FOLLOWED THE PROMPTS DURING THE LOAD SEQUENCE. ADDITIONALLY, A CARTRIDGE ALARM 6 OCCURRED WHILE WITHIN THE ALLOWABLE OPERATING ALTITUDE RANGE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 150-199 MG/DL. REPORTEDLY, CUSTOMER REVERTED TO A BACKUP PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624114 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0386003 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female INSULIN: HUMALOGINFUSION SET: AUTOSOFT 90