BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 7511216 · Received May 14, 2018

    Report

    Report Number
    3013756811-2018-16092
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Date of Event
    April 21, 2018
    Report Date
    May 14, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:SLIM PUMP USER GUIDE INSTRUCTS THE USER TO REMOVE ANY RESIDUAL AIR FROM THE CARTRIDGE. THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN GAUGE DECREASED TO AN INACCURATE FILL ESTIMATE OF 10 UNITS. REPORTEDLY, THE CARTRIDGE WAS FILLED WITH 300 UNITS OF INSULIN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 192-204 MG/DL. REPORTEDLY, THE CUSTOMER RELOADED THE SAME CARTRIDGE AND RECEIVED A MINIMUM FILL NOTIFICATION. UPON TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT IT WAS DISCOVERED THE CUSTOMER WAS NOT REMOVING RESIDUAL AIR FROM THE CARTRIDGE BEFORE ADDING INSULIN. REPORTEDLY, THE CUSTOMER LOADED A NEW CARTRIDGE SUCCESSFULLY AND RECEIVED AN ACCURATE FILL ESTIMATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353509 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR