BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6105837 · Received November 16, 2016

    Report

    Report Number
    3007981285-2016-19299
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    October 26, 2016
    Report Date
    October 26, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 CHARGE PROPERLY WITHOUT THE CUSTOMER MANEUVERING THE CABLE INTO THE CHARGING PORT AT A CERTAIN ANGLE, IN ORDER TO COMPLETE A SUCCESSFUL CHARGE. THE CUSTOMER ATTEMPTED MULTIPLE CABLES AND STATED THAT THE USB CABLES FIT VERY LOOSELY INTO THE USB PORT. CUSTOMER REPORTED BLOOD GLUCOSE (BG) LEVEL WAS IMPACTED (336 MG/DL). THE CUSTOMER STATED THEY HAD INSULIN ON BOARD 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
    757588 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other