BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 5792507 · Received July 13, 2016

    Report

    Report Number
    3007981285-2016-91496
    Event Type
    Injury
    Date Received
    July 13, 2016
    Date of Event
    June 10, 2016
    Report Date
    June 24, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED ONGOING ELEVATED BLOOD GLUCOSE LEVELS BETWEEN 200-503 (MG/DL). A PUMP BOLUS WAS DELIVERED TO ADDRESS BG LEVELS. RECOMMENDATION WAS MADE TO CONSULT WITH THEIR HEALTH CARE PROVIDER TO DISCUSS DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446367 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other