BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6963450 · Received October 19, 2017

    Report

    Report Number
    3007981285-2017-30558
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Date of Event
    September 27, 2017
    Report Date
    October 19, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL LOT NUMBER WAS REPORTED (LOT #: M020465). THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INACCURATE FILL ESTIMATE AFTER LOADING A CARTRIDGE. REPORTEDLY, THE CARTRIDGE WAS FILLED WITH 300 UNITS OF INSULIN, AND AFTER DELIVERING APPROXIMATELY 20 UNITS, THE INSULIN GAUGE UPDATED TO 95 UNITS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 130 MG/DL. REPORTEDLY, WHEN THE AMOUNT OF INSULIN INSIDE THE CARTRIDGE REACHED 95 UNITS, THE INSULIN GAUGE DECREASED AS EXPECTED. THE CUSTOMER REPORTED THAT THE PUMP WOULD CONTINUE TO BE USED FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740296 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M020191

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR