BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6041861 · Received October 19, 2016

    Report

    Report Number
    3007981285-2016-15374
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    August 26, 2016
    Report Date
    September 26, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 MULTIPLE INTERMITTENT OCCLUSION ALARMS OCCURRED FOR THE PAST MONTH. THE CUSTOMER REPORTED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL ABOVE 300 (MG/DL). DUE TO THE SUPPLIES BEING CHANGED, TROUBLESHOOTING TO DETERMINE THE SOURCE OF OCCLUSION WAS UNABLE TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692377 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other