BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6124788 · Received November 23, 2016

    Report

    Report Number
    3007981285-2016-21955
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    November 5, 2016
    Report Date
    November 5, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP BATTERY JUMPED FROM (B)(4)% TO (B)(4)%. FOLLOWING THE BATTERY JUMP, THE BATTERY DEPLETED AS NORMAL. CUSTOMER REPORTED BLOOD GLUCOSE LEVEL WAS 119 (MG/DL). THE CUSTOMER DECLINED TO UPLOAD THE PUMP DATA FOR REVIEW BY TANDEM TECHNICAL SUPPORT. REPORTEDLY, THE CUSTOMER WILL CONTINUE TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775550 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR