BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3708135 · Received March 28, 2014

    Report

    Report Number
    3004753838-2014-19280
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    June 13, 2013
    Report Date
    June 13, 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 CONFIRMED THE INTERMITTENT OUF OF RANGE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184320 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE: MDS MDS DEXCOM INC 9348-01

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR