BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4941637 · Received July 26, 2015

    Report

    Report Number
    3004753838-2015-65020
    Event Type
    Malfunction
    Date Received
    July 26, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 1, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CARE TAKER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT CONTINUOUS GLUCOSE MONITOR (CGM) INACCURACY COMPARED TO BLOOD GLUCOSE (BG) METER ON (B)(6) 2015. SENSOR WAS INSERTED ON (B)(6) 2015. CARE TAKER DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485444 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5199097

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR