BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 8812864 · Received July 22, 2019

    Report

    Report Number
    3013756811-2019-20657
    Event Type
    Malfunction
    Date Received
    July 22, 2019
    Date of Event
    April 1, 2019
    Report Date
    July 22, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004385
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POSSIBLE USE ERRORS: USING COLD INSULIN AND OVERFILLING THE CARTRIDGE BAG. PER TANDEM¿S T:FLEX USER GUIDE: "INSULIN SHOULD BE AT ROOM TEMPERATURE BEFORE FILLING CARTRIDGE" AND ¿THE SINGLE-USE DISPOSABLE CARTRIDGE CAN HOLD UP TO 480 UNITS (4.8 ML) OF INSULIN.¿ PUMP SERIAL NUMBERS: (B)(4). CARTRIDGE LOT NUMBERS: M022013, M022173, M111342, M140187, M172910, M173516.

    Description of Event or Problem · 1

    QUARTERLY SUMMARY REPORT FOR ALLEGED INSULIN GAUGE ISSUES: IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE OR A MINIMUM FILL NOTIFICATION WAS RECEIVED AFTER THE CARTRIDGE WAS FILLED WITH A SUFFICIENT AMOUNT OF INSULIN. THE ISSUE WAS RESOLVED BY LOADING A NEW CARTRIDGE OR REVERTING TO AN ALTERNATE METHOD OF INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606249 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 00852162004385

    Patients

    Seq Age Sex Outcome Treatment
    1 INFUSION SET, INSULIN