BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 9396913 · Received December 2, 2019

    Report

    Report Number
    3013756811-2019-85838
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 19, 2019
    Report Date
    December 2, 2019
    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 · 1

    PER TANDEM'S USER GUIDE, "DO NOT DELIVER A BOLUS UNTIL YOU HAVE REVIEWED THE CALCULATED BOLUS AMOUNT ON THE PUMP DISPLAY. IF YOU DOSE AN INSULIN AMOUNT THAT IS TOO HIGH OR TOO LOW, THIS COULD CAUSE VERY HIGH OR VERY LOW BLOOD GLUCOSE. YOU CAN ALWAYS ADJUST THE INSULIN UNITS UP OR DOWN BEFORE YOU DECIDE TO DELIVER YOUR BOLUS." THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE ALARMS AND OCCLUSION ALARMS OCCURRED. ADDITIONALLY, IT WAS REPORTED THAT THE CUSTOMER DISLIKED THE BOLUS MENU AS MISTAKES IN ENTERING THE CARBOHYDRATE VALUE INTO THE UNITS WERE OFTEN MADE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TROUBLESHOOTING THE REPORTED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193146 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 27 YR