BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6336427 · Received February 16, 2017

    Report

    Report Number
    3007981285-2017-04094
    Event Type
    Injury
    Date Received
    February 16, 2017
    Date of Event
    January 25, 2017
    Report Date
    February 16, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 ELEVATED BLOOD GLUCOSE LEVELS (250-350 MG/DL). CUSTOMER'S HEALTH CARE PROFESSIONAL RECOMMENDED PUMP BASAL RATE BE INCREASED. TANDEM TECHNICAL SUPPORT GUIDED THE CUSTOMER THROUGH ADJUSTING PUMP BASAL RATE. CUSTOMER STATED ELEVATED BLOOD WILL BE ADDRESSED WITH SETTINGS ADJUSTMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119287 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other