BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 8740856 · Received June 27, 2019

    Report

    Report Number
    3013756811-2019-36162
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    June 4, 2019
    Report Date
    June 27, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007295
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 INTERMITTENT POWER SOURCE ALERTS AFTER PLUGGING THE PUMP INTO A WALL OUTLET USING THE TANDEM-PROVIDED WALL ADAPTER. ADDITIONALLY, THE BATTERY GAUGE WAS OBSERVED TO BE FLUCTUATING. THE CUSTOMER'S BLOOD GLUCOSE RANGED FROM 191-208 MG/DL. REPORTEDLY, THE ALERT CLEARED AND THE PUMP SUCCESSFULLY BEGAN CHARGING AFTER THE CUSTOMER USED AN ALTERNATE WALL ADAPTER TO CHARGE THE PUMP. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534798 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007295

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR