BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6073340 · Received November 2, 2016

    Report

    Report Number
    3007981285-2016-18109
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 10, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) LEVELS BETWEEN 240-364 (MG/DL) AND MODERATE KETONES FOR A WEEK. THE PUMP BASAL RATE WAS INCREASED AND BOLUSES WERE DELIVERED TO ADDRESS BG LEVEL AND WATER WAS CONSUMED TO FLUSH KETONES. RECOMMENDATION WAS MADE TO CONSULT WITH A HEALTH CARE PROVIDER TO DISCUSS DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724309 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other