BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6684329 · Received July 3, 2017

    Report

    Report Number
    3007981285-2017-18733
    Event Type
    Injury
    Date Received
    July 3, 2017
    Date of Event
    June 10, 2017
    Report Date
    July 3, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 (BG) LEVEL WAS 133-350 (MG/DL) AT THE TIME OF THE EVENTS. A BOLUS VIA THE PUMP WAS DELIVERED TO ADDRESS BG LEVEL. REPORTEDLY THE CUSTOMER WOULD CONTINUE TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465398 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other