BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6649922 · Received June 19, 2017

    Report

    Report Number
    3007981285-2017-16534
    Event Type
    Injury
    Date Received
    June 19, 2017
    Date of Event
    May 13, 2017
    Report Date
    June 19, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 (250-350 MG/DL) AND INSULIN INJECTIONS WERE ADMINISTERED TO ADDRESS THE BG LEVEL. THE CAUSE OF THE HIGH BG WAS NOT KNOWN. THE CUSTOMER DECLINED TANDEM TECHNICAL SUPPORT'S OFFER TO TROUBLESHOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430886 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other