BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3954074 · Received July 23, 2014

    Report

    Report Number
    3004753838-2014-24634
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 27, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEXCOM REVIEWED RECEIVER DATA ON (B)(4) 2014. DATA CONFIRMED SOME READINGS WERE OUTSIDE OF THE 20 PERCENT/20 POINT DIFFERENCE RANGE

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT CGM INACCURACIES COMPARED TO BLOOD GLUCOSE METER ON (B)(6) 2014. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, THE PATIENT DID NOT REPORT ANY MEDICAL INTERVENTION OR INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430894 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5120281

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other