BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 12135456 · Received July 8, 2021

    Report

    Report Number
    3013756811-2021-70508
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    June 18, 2021
    Report Date
    July 8, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP SHUT OFF UNEXPECTEDLY. CUSTOMER CONFIRMED PUMP DISPLAY TURNED ON WHEN PLUGGED INTO A POWER SOURCE. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 150-190 MG/DL. CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034819 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR