BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13584839 · Received February 23, 2022

    Report

    Report Number
    3013756811-2022-19652
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    February 9, 2022
    Report Date
    February 9, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 162-172 UNITS OF INSULIN DURING THE LOAD SEQUENCE WITH MULTIPLE CARTRIDGES. ADDITIONALLY, IT WAS REPORTED THAT THE TOUCHSCREEN WAS INTERMITTENTLY UNRESPONSIVE. REPORTEDLY, THE CUSTOMER PERFORMED A PUMP RESET PRIOR TO TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, AND THE TOUCHSCREEN RESPONDED TO PRESSES. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY, AND THE PUMP WAS REPLACED TO MAINTAIN CUSTOMER SATISFACTION. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 120-445 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905558 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female INFUSION SET: AUTOSOFT 90INSULIN: NOVOLOG / NOVOR