BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6071130 · Received November 1, 2016

    Report

    Report Number
    3007981285-2016-16737
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    October 8, 2016
    Report Date
    October 9, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE (BG) LEVELS (298 MG/DL). THE CUSTOMER EXERCISED, CHANGED SUPPLIES, AND DELIVERED A BOLUS TO ADDRESS BG LEVEL. THE CAUSE OF THE HIGH BG LEVELS WERE UNKNOWN. TANDEM TECHNICAL SUPPORT RECOMMENDED TO THE CUSTOMER TO CONSULT THEIR HEALTHCARE PROVIDER REGARDING THE HIGH BG LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721712 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other