BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6037716 · Received October 18, 2016

    Report

    Report Number
    3007981285-2016-14670
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 26, 2016
    Report Date
    September 26, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 THE WAKE BUTTON HAS STOPPED FUNCTIONING. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, IT WAS CONFIRMED THAT THE PUMP STILL TURNS ON WHEN PLUGGED INTO A POWER SOURCE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED. REPORTEDLY, CUSTOMER WILL CONTINUE TO USE THE PUMP FOR INSULIN THERAPY, AND INDICATED THAT INSULIN INJECTIONS ARE AVAILABLE FOR ALTERNATE INSULIN THERAPY IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687271 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR