BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3714385 · Received March 31, 2014

    Report

    Report Number
    3004753838-2014-19262
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    May 30, 2013
    Report Date
    May 30, 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). EVALUATION OF THE RETURNED DEVICE DID NOT CONFIRM THE PERMANENT OUT OF RANGE SIGNAL.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RETURNED; HOWEVER, A TRANSMITTER (SN (B)(4)/ MFG DATE: 12/04/2012) WAS 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
    192369 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE: MDS MDS DEXCOM INC 9348-01

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR