BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 7296144 · Received February 26, 2018

    Report

    Report Number
    3013756811-2018-05487
    Event Type
    Malfunction
    Date Received
    February 26, 2018
    Date of Event
    February 3, 2018
    Report Date
    February 26, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET. THE BATTERY GAUGE THEN JUMPED FROM 20% TO 100% AFTER BEING DISCONNECTED FROM THE POWER SOURCE. THE CUSTOMER'S BLOOD GLUCOSE WAS 122-124 (MG/DL). REPORTEDLY THE CUSTOMER WOULD CONTINUE TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139575 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR