BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6331537 · Received February 15, 2017

    Report

    Report Number
    3007981285-2017-03749
    Event Type
    Injury
    Date Received
    February 15, 2017
    Date of Event
    January 23, 2017
    Report Date
    February 15, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CONTACT THAT THE CUSTOMER HAD BEEN EXPERIENCING ONGOING HIGH BLOOD GLUCOSE (BG) LEVELS (202-285 MG/DL) WITH A TRACE OF KETONES. THE CUSTOMER WENT TO THE EMERGENCY ROOM AND INSULIN INJECTIONS WERE ADMINISTERED. THE CUSTOMER LEFT THE ER THE NEXT MORNING. THE PUMP CARTRIDGE WAS CHANGED. THE CUSTOMER WAS FEELING BETTER; HOWEVER, THE BG LEVEL WAS STILL HIGH. A BOLUS OF INSULIN WAS DELIVERED. THE CUSTOMER DID NOT KNOW THE CAUSE OF THE HIGH BG. A PUMP SYSTEM CHECK WAS PERFORMED USING THE CURRENT SUPPLIES ON THE PUMP AND NO DEVICE ISSUES WERE FOUND. THE CONTACT WAS SATISFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114143 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention