BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORS

    MDR report key: 3719492 · Received April 1, 2014

    Report

    Report Number
    3004753838-2014-15405
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    September 6, 2013
    Report Date
    September 7, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENT TO THE INITIAL MDR, IT WAS NOTICED THAT THIS WAS DUPLICATE INFORMATION WHICH HAS BEEN PROVIDED ON (MDR #3004753838-2014-19378 ). THE INITIAL MDR FOR THIS REPORT (MDR#3004753838-2014-15405) SHOULD NOT HAVE BEEN SUBMITTED.

    Description of Event or Problem · 1

    CONSUMER REPORTED PERMANENT OUT OF RANGE SIGNAL. THE CONSUMER DID NOT REPORT ANY MEDICAL INTERVENTION OR INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195671 G4 PLATINUM CONTINUOUS GLUCOSE MONITORS MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR