BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 10206702 · Received June 29, 2020

    Report

    Report Number
    3013756811-2020-66447
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    June 9, 2020
    Report Date
    June 29, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007301
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RESISTANCE WAS FELT WHEN FILLING THE CARTRIDGE DURING THE LOAD SEQUENCE ON MULTIPLE CARTRIDGES. CUSTOMER CHANGED THE NEEDLE AND CARTRIDGES TO RESOLVE THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE RANGED FROM 142-148 MG/DL. IN ADDITION, IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED TO BE COMING OUT OF THE CARTRIDGES. CUSTOMER CHANGED THE CARTRIDGE TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672165 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007301

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR