BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3717267 · Received April 1, 2014

    Report

    Report Number
    3004753838-2014-18044
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    January 15, 2013
    Report Date
    January 15, 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 AND REVIEW OF THE DATA LOG CONFIRMED THE PERMANENT OUT OF RANGE SIGNAL. DATA WAS RECEIVED (B)(6) 2013. A TRANSMITTER (SN (B)(4), MFG DATE: 12/04/2012) WAS ALSO RETURNED FOR EVALUATION AND THERE WAS NO ISSUE DETECTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE AND REVIEW OF THE DATA LOG DID NOT CONFIRM THE REPORTED PERMANENT LOSS OF "Y".

    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
    195880 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE:MDS MDS DEXCOM INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR