BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4892900 · Received July 6, 2015

    Report

    Report Number
    3004753838-2015-23010
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 10, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 AND CLAIMED THAT ON (B)(6) 2015 THE PATIENT EXPERIENCED A HARDWARE FAILURE. THE PATIENT'S MOTHER DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435397 DEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT22430-BLU 5195973

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR