BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3842337 · Received June 1, 2014

    Report

    Report Number
    3004753838-2014-08384
    Event Type
    Malfunction
    Date Received
    June 1, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 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

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR INVESTIGATION. HOWEVER, DATA WAS RECEIVED AND DOWNLOADED ON (B)(4) 2014. A REVIEW OF THE DOWNLOADED DATA LOG CONFIRMED THE REPORTED EVENT OF INACCURATE BLOOD GLUCOSE VALUES.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320667 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5131462

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other