BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6051379 · Received October 24, 2016

    Report

    Report Number
    3007981285-2016-15566
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 3, 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

    IT WAS REPORTED THAT THE CUSTOMER HAD EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) LEVELS OVER THE PAST 3 DAYS RANGE (230-270 MG/DL) THE CUSTOMER WOULD BOLUS TO STABILIZE BG LEVEL. THE SUSPECTED CAUSE FOR THE ELEVATED BG LEVELS WAS DUE TO BASAL RATE SETTINGS. TROUBLESHOOTING COULD NOT BE PERFORMED WITH TANDEM TECHNICAL SUPPORT AS THE ALLEGED ISSUE OCCURRED IN THE PAST. IT WAS INDICATED THAT THE HEALTH CARE PROVIDER (HCP) REQUESTED THE BASAL RATE SETTINGS BE CHANGE. THE CUSTOMER WAS ASSISTED IN CHANGING THE BASAL RATE SETTINGS ON THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700888 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other