BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 12934053 · Received December 6, 2021

    Report

    Report Number
    3013756811-2021-132600
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 23, 2021
    Report Date
    December 6, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED IN THE INFUSION SET TUBING. TANDEM TECHNICAL SUPPORT GUIDED THE CUSTOMER THROUGH PRIMING THE AIR BUBBLES OUT. REPORTEDLY, THE ISSUE RESOLVED AND INSULIN DELIVERY WAS RESUMED. ADDITIONALLY, IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET. REPORTEDLY, THE ALERT CLEARED AND THE PUMP SUCCESSFULLY BEGAN CHARGING AFTER LEAVING THE PUMP PLUGGED INTO THE POWER SOURCE. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 180-465 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833373 T:SLIM X2 INSULIN PUMP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female