BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6926059 · Received October 7, 2017

    Report

    Report Number
    3007981285-2017-29531
    Event Type
    Injury
    Date Received
    October 7, 2017
    Date of Event
    September 15, 2017
    Report Date
    October 6, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 THAT THE CUSTOMER HAD BEEN EXPERIENCING ONGOING HIGH BLOOD GLUCOSE (BG) LEVELS 220-330 MG/DL. CORRECTION BOLUSES WERE DELIVERED TO ADDRESS THE BG LEVEL. THE INFUSION SET SITE WAS CHANGED AND NO ISSUE WAS OBSERVED WITH THE CANNULA. THE CUSTOMER WAS RECOVERING FROM A SICKNESS AND WAS NOT SURE IF THIS WAS CONTRIBUTING TO THE HIGH BG. A PUMP SYSTEM CHECK WAS PERFORMED AND NO DEVICE ISSUES WERE IDENTIFIED. THE CUSTOMER WAS SATISFIED WITH THE RESULTS OF THE SYSTEM CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705626 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other