BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6183214 · Received December 16, 2016

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    Report

    Report Number
    3007981285-2016-24671
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    November 24, 2016
    Report Date
    November 28, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 RANGING BETWEEN 400 MG/DL TO ABOVE 500 MG/DL. THE CUSTOMER DELIVERED A BOLUS VIA THE PUMP TO STABILIZE BG LEVEL. THE CONTACT STATED THE SUSPECTED CAUSE FOR THE HIGH BG LEVELS WAS DUE TO NOT DELIVERING A FOOD BOLUS PRIOR TO EATING A THANKSGIVING MEAL. A RECOMMENDATION WAS MADE FOR THE CUSTOMER TO CONTACT THE HEALTHCARE PROVIDER TO DISCUSS FACTORS THAT MAY AFFECT BG LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834255 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other