BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 7115453 · Received December 13, 2017

    Report

    Report Number
    3007981285-2017-38360
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    December 3, 2017
    Report Date
    December 13, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM¿S T:FLEX USER GUIDE ¿THE SINGLE-USE DISPOSABLE CARTRIDGE CAN HOLD UP TO 480 UNITS (4.8ML) OF INSULIN.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE, INACCURATE FILL ESTIMATES AFTER LOADING CARTRIDGES WITH 500 UNITS OF INSULIN. REPORTEDLY, THE INITIAL FILL ESTIMATE DISPLAYED WAS ACCURATE, HOWEVER, THE INSULIN GAUGE DECREASED TO A FILL ESTIMATE OF APPROXIMATELY 20 UNITS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 210-340 (MG/DL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893553 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 M020881

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR