BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9881170 · Received March 25, 2020

    Report

    Report Number
    3013756811-2020-30039
    Event Type
    Injury
    Date Received
    March 25, 2020
    Date of Event
    December 3, 2019
    Report Date
    March 25, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007325
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT THE TOUCH SCREEN APPEARED TO BE PUSHING BUTTONS WITHOUT THE CUSTOMER ACTUALLY TOUCHING THE SCREEN. IN ADDITION, IT WAS REPORTED THAT THE BATTERY WAS DEPLETING FASTER THAN EXPECTED. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, IT WAS DETERMINED THAT THE BATTERY WAS DEPLETING AS EXPECTED. CUSTOMER MAINTAINED ALLEGATION. CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED 232-580 MG/DL. CUSTOMER ADMINISTRATED A MANUAL INJECTION TO ADDRESS HIGH BLOOD GLUCOSE LEVEL. CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340733 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007325

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other