BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 6311682 · Received February 8, 2017

    Report

    Report Number
    3007981285-2017-02731
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    December 1, 2016
    Report Date
    February 8, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 BEEN EXPERIENCING ONGOING HIGH BLOOD GLUCOSE (BG) LEVELS (250-350 MG/DL) AND A BOLUS VIA THE PUMP WAS DELIVERED TO ADDRESS THE BG LEVEL. THE CUSTOMER SUSPECTED THAT A RECENT BACK SURGERY AND AN INFECTION WAS THE CAUSE OF THE HIGH BG AND THE PUMP/SUPPLIES WERE NOT RELATED TO THE ONGOING HIGH BG. TANDEM TECHNICAL SUPPORT ADVISED THE CUSTOMER TO DISCUSS THE HIGH BG WITH A HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94295 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other INFUSION SET: INSET, INSULIN: HUMALOG