BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 7072971 · Received November 30, 2017

    Report

    Report Number
    3007981285-2017-35855
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 10, 2017
    Report Date
    November 30, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 NEEDED TO APPLY MORE PRESSURE ON THE TOUCHSCREEN OR CLICK A BUTTON MULTIPLE TIMES IN ORDER FOR THE SCREEN TO RESPOND. ADDITIONALLY, IT WAS REPORTED THAT THE CUSTOMER NEEDED TO PRESS THE WAKE BUTTON MULTIPLE TIMES IN ORDER FOR BUTTON TO RESPOND. BLOOD GLUCOSE RANGED FROM 113-118 MG/DL. REPORTEDLY, THE CUSTOMER DROPPED THE PUMP, BUT DID NOT SEE ANY DAMAGE TO THE PUMP. THE CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM'S TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851826 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR