BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 5760398 · Received June 29, 2016

    Report

    Report Number
    3007981285-2016-88764
    Event Type
    Injury
    Date Received
    June 29, 2016
    Date of Event
    June 8, 2016
    Report Date
    June 8, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE NOT RETURNED.

    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 HAD ELEVATED BLOOD GLUCOSE LEVELS (250-350 MG/DL). CUSTOMER USED MANUAL INJECTIONS TO STABILIZE BLOOD GLUCOSE LEVELS. IT WAS INDICATED THAT THE CUSTOMER HAS A BACK UP METHOD FOR CONTINUED INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414857 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other