BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 6122389 · Received November 22, 2016

    Report

    Report Number
    3007981285-2016-20921
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 1, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM¿S T:FLEX USER GUIDE: ¿ONLY HUMALOG AND NOVOLOG HAVE BEEN TESTED BY TANDEM DIABETES CARE, INC., AND FOUND TO BE COMPATIBLE FOR USE IN THE T:FLEX SYSTEM. IT IS NOT INTENDED FOR USE WITH ANY OTHER DELIVERY SUBSTANCE.¿ ALSO, "USE OF CARTRIDGES NOT MANUFACTURED BY TANDEM DIABETES CARE, INC. OR REUSE OF CARTRIDGES MAY RESULT IN OVER-INFUSION OR UNDER-INFUSION AND MAY CAUSE SERIOUS INJURY OR DEATH.¿ 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 REUSED A CARTRIDGE AND THE CARTRIDGE BEGAN LEAKING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 120 MG/DL. TANDEM TECHNICAL SUPPORT ADVISED NOT TO REUSE CARTRIDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771911 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR