BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6159630 · Received December 9, 2016

    Report

    Report Number
    3007981285-2016-23686
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 22, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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'S BLOOD GLUCOSE LEVEL WAS ELEVATED (241-321 MG/DL). CUSTOMER STATED ELEVATED BG WAS DUE TO INCORRECTLY COUNTING THE AMOUNT OF CARBOHYDRATES THEY CONSUMED. CUSTOMER DECLINED TO PERFORM TROUBLESHOOTING. A BOLUS WAS DELIVERED TO STABILIZE BG LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813876 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other