BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 5666371 · Received May 19, 2016

    Report

    Report Number
    3007981285-2016-80567
    Event Type
    Injury
    Date Received
    May 19, 2016
    Date of Event
    March 23, 2016
    Report Date
    April 27, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THE CUSTOMER'S INSULIN PUMP HAS FALLEN OUT OF THE T:CLIP HOLDER ON MULTIPLE OCCASIONS, PULLING OUT THE CANNULA OF THE INFUSION SET. CUSTOMER REPORTS ELEVATED BLOOD GLUCOSE (BG) LEVELS OF 284-380 MG/DL. REPORTEDLY THE CUSTOMER USES INSULIN INJECTIONS TO ADDRESS THE HIGH BG'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321318 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other INSULIN: NOVOLOG INFUSION SET: INSET