BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 5982301 · Received September 27, 2016

    Report

    Report Number
    3004753838-2016-22656
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    September 4, 2016
    Report Date
    September 4, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    UDI-DI
    00386270000019
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, THERE WAS A CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACY COMPARED TO BLOOD GLUCOSE (BG) METER THAT OCCURRED . THE SENSOR WAS INSERTED ON THE ABDOMEN, ON (B)(6) 2016. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630774 T:SLIM G4 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC DEXCOM, INC. 9500-27 5214789 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR