BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4850715 · Received June 17, 2015

    Report

    Report Number
    3004753838-2015-05023
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 25, 2015
    Report Date
    May 25, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE DATA LOG WAS PROVIDED BY THE PATIENT. THE DATA WAS REVIEWED ON (B)(4) 2015 AND CONFIRMED THE REPORTED EVENT OF INTERMITTENT OUT OF RANGE. A DEFINITIVE ROOT CAUSE, HOWEVER, COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT THAT ON (B)(6) 2015, PATIENT EXPERIENCED AN INTERMITTENT OUT OF RANGE SIGNAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395114 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-05 5197274

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR