BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 8764300 · Received July 5, 2019

    Report

    Report Number
    3013756811-2019-37201
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 12, 2019
    Report Date
    July 5, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    UDI-DI
    10386270000221
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 TRANSMITTER LOST CONNECTION WITH THE PUMP FOR OVER 1 HOUR. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. REPORTEDLY, THE PUMP AND TRANSMITTER REGAINED CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558326 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC DEXCOM, INC. 9438-06 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1