BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6411202 · Received March 16, 2017

    Report

    Report Number
    3007981285-2017-08006
    Event Type
    Injury
    Date Received
    March 16, 2017
    Date of Event
    February 10, 2017
    Report Date
    March 16, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 CONTINOUS HIGH BLOOD GLUCOSE LEVELS OF 250 - 350 MG/DL. THE CUSTOMER DELIVERED A CORRECTION BOLUS AND ADMINISTERED A MANUAL INJECTION TO ADDRESS BG LEVEL. THE CONTACT STATED THE CAUSE OF THE HIGH BG LEVELS WERE DUE TO SETTINGS AND HAD BEEN IN CONTACT WITH THEIR HEALTHCARE PROVIDER REGARDING THE SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194077 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other INFUSION SET: INSET INSULIN: HUMALOG