BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 9241976 · Received October 25, 2019

    Report

    Report Number
    3013756811-2019-71760
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Date of Event
    October 3, 2019
    Report Date
    October 25, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    852162004439
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP COULD NOT BE CHARGED DESPITE THE ATTEMPT OF MULTIPLE USB CABLES, WALL ADAPTERS AND POWER SOURCES. THE CUSTOMER¿S BLOOD GLUCOSE WAS 113-259 (MG/DL). REPORTEDLY THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032383 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003 852162004439

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR