BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 9377087 · Received November 26, 2019

    Report

    Report Number
    3013756811-2019-81936
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    November 7, 2019
    Report Date
    November 26, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 122-123 MG/DL. A SYSTEM CHECK WAS PERFORMED AND THE PUMP PERFORMED AS INTENDED. REPORTEDLY, THE CUSTOMER REVERTED TO ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172193 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