BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3707988 · Received March 28, 2014

    Report

    Report Number
    3004753838-2014-19149
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    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 TRANSMITTER CONFIRMED THE PERMANENT OUT OF RANGE SIGNAL. A RECEIVER (SN (B)(4), MFG DATE: 11/02/2012) WAS ALSO RETURNED FOR EVALUATION AND THERE WAS NO ISSUE DETECTED.

    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
    186484 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM INC. 9438-01

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR