BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6614989 · Received June 6, 2017

    Report

    Report Number
    3007981285-2017-15364
    Event Type
    Malfunction
    Date Received
    June 6, 2017
    Date of Event
    May 12, 2017
    Report Date
    June 6, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 MULTIPLE MALFUNCTION ALARMS OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 130 - 131 MG/DL. THE CUSTOMER REPORTED THAT MANUAL INJECTIONS WOULD CONTINUE TO BE USED FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395850 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR