BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6815217 · Received August 23, 2017

    Report

    Report Number
    3007981285-2017-23948
    Event Type
    Injury
    Date Received
    August 23, 2017
    Date of Event
    June 5, 2017
    Report Date
    August 23, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 INTERMITTENT ELEVATED BLOOD GLUCOSE (BG) LEVELS (APPROXIMATELY 230-500 MG/DL). REPORTEDLY, THE CUSTOMER ADJUSTED THE PUMP CARBOHYDRATE RATIO WITHOUT GUIDANCE FROM THE CUSTOMER'S HEALTH CARE PROFESSIONAL. REPORTEDLY, THE CUSTOMER CONSULTED WITH THEIR HEALTH CARE PROFESSIONAL ABOUT ADJUSTING THE PUMP SETTINGS. CUSTOMER DELIVERED A BOLUS AND ADMINISTERED MANUAL INJECTIONS TO ADDRESS ELEVATED BG LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595837 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other