BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORS

    MDR report key: 3719564 · Received April 1, 2014

    Report

    Report Number
    3004753838-2014-15438
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    October 10, 2013
    Report Date
    October 10, 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

    EVALUATION OF THE RETURNED RECEIVER DID NOT CONFIRM PERMANENT OUT OF RANGE SIGNAL. A TRANSMITTER (SN (B)(4), MNF DATE: 05/15/2013) WAS ALSO RETURNED FOR EVALUATION AND THERE WAS NO ISSUE DETECTED.

    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 #3004753838-2014-19419). THE INITIAL MDR FOR THIS REPORT (MDR#3004753838-2014-15438) 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
    193901 G4 PLATINUM CONTINUOUS GLUCOSE MONITORS MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR