BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6064312 · Received October 28, 2016

    Report

    Report Number
    3007981285-2016-17036
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    September 26, 2016
    Report Date
    October 6, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE INTERMITTENT OCCLUSION ALARM OCCURRED. REPORTEDLY, WHEN THE CUSTOMER DISCONNECTED THEIR SITE AND DELIVERED A TEST BOLUS, INSULIN WAS NOT OBSERVED EXITING THE TUBING; HOWEVER, INSULIN EXITED THE CARTRIDGE. THIS PROMPTED THE CUSTOMER TO CHANGE THE TUBING WHICH THE CUSTOMER BELIEVED WAS THE SOURCE OF THE OCCLUSION. THE CUSTOMER REPORTED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL OF 549 (MG/DL). A CORRECTION BOLUS WAS DELIVERED TO ADDRESS BG LEVELS. DUE TO THE OCCLUSION OCCURRING IN THE PAST AND SUPPLIES BEING CHANGED, TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT WAS UNABLE TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716159 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other