BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6063504 · Received October 28, 2016

    Report

    Report Number
    3007981285-2016-16064
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    October 1, 2016
    Report Date
    October 6, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 BLOOD GLUCOSE (BG) LEVELS RANGE (230-264 MG/DL) THE CUSTOMER TOOK BOLUSES VIA THE PUMP TO STABILIZE BG LEVELS. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT (CTS), A SYSTEM CHECK WAS PERFORMED AND INDICATED THAT THE PUMP WAS FUNCTIONING AS INTENDED. THE CUSTOMER STATED TO BE A LITTLE STRESSED OUT DUE TO HUSBAND DIAGNOSED WITH PANCREATIC CANCER. 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
    714400 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other INSULIN: NOVOLOG, INFUSION SET: INSET