BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5676879 · Received May 24, 2016

    Report

    Report Number
    3007981285-2016-81317
    Event Type
    Injury
    Date Received
    May 24, 2016
    Date of Event
    April 4, 2016
    Report Date
    May 2, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    THE CONTACT REPORTED THE CUSTOMER HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE (BG) LEVELS OF 230-350 MG/DL FOR 3 TO 4 WEEKS. THE CUSTOMER ADDRESSED THE HIGH BG'S WITH A BOLUS OF INSULIN VIA THE PUMP. THE CUSTOMER HAS BEEN WORKING WITH THE HEALTH CARE PROFESSIONAL ON MAKING SETTINGS ADJUSTMENTS. CUSTOMER RECENTLY CONTACTED THEIR HEALTH CARE PROFESSIONAL WHO ADVISED NEW BASAL SETTINGS CHANGED FROM .5 TO .55 AND INSULIN TO CARB RATIO TO 1U PER 12 GRAMS OF CARBOHYDRATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330728 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other