BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6085993 · Received November 8, 2016

    Report

    Report Number
    3007981285-2016-18824
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 18, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    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 THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE LEVEL OF 250 (MG/DL). REPORTEDLY, THE CUSTOMER REQUIRED ASSISTANCE TURNING ON THEIR PUMP AND NAVIGATING THEIR PUMP SETTINGS. THE CUSTOMER STATED THEY WOULD DELIVER A BOLUS AFTER BEING GUIDED THROUGH HOW TO ENTER THEIR PUMP SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738708 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other