BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6122059 · Received November 22, 2016

    Report

    Report Number
    3007981285-2016-20607
    Event Type
    Injury
    Date Received
    November 22, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 PUMP COULD NOT BE CHARGED DESPITE THE ATTEMPT OF MULTIPLE USB CABLES AND WALL ADAPTERS. CUSTOMER REPORTED BLOOD GLUCOSE (BG) LEVEL WAS 64 (MG/DL). THE CUSTOMER CONSUMED FOOD TO ADDRESS BG LEVEL. REPORTEDLY THE CUSTOMER WILL CONTINUE TO USE THE PUMP UNTIL THE REPLACEMENT PUMP IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773665 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other