BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 7024750 · Received November 13, 2017

    Report

    Report Number
    3007981285-2017-33180
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 6, 2017
    Report Date
    November 13, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:SLIM PUMP USER GUIDE CAUTIONS AGAINST OVERFILLING A CARTRIDGE PAST 300 UNITS AS THIS CAN LEAD TO CARTRIDGE ERROR. 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 MULTIPLE, INTERMITTENT INACCURATE FILL ESTIMATES AFTER LOADING MULTIPLE CARTRIDGES. REPORTEDLY, ON SOME OCCASIONS, THE CARTRIDGE WAS FILLED WITH OVER 300 UNITS OF INSULIN, AND THE INSULIN GAUGE DECREASED FASTER THAN EXPECTED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 170-371 MG/DL. REPORTEDLY, THE CUSTOMER CONTINUED USING THE PUMP FOR CONTINUED INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804583 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003 M020279

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR