BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4944490 · Received July 28, 2015

    Report

    Report Number
    3004753838-2015-31857
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    June 29, 2015
    Report Date
    June 29, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED TO DEXCOM FOR EVALUATION. HOWEVER, DATA WAS RECEIVED AND DOWNLOADED. A REVIEW OF THE DOWNLOADED RECEIVER LOG DID NOT FIND ANY ERRORS RELATED TO THE CUSTOMER COMPLAINT. THE REPORTED EVENT OF NO AUDIO OUTPUT WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON 06/29/2015 TO REPORT NO AUDIO OUTPUT FROM THEIR DEXCOM RECEIVER ON (B)(6) 2015. ADDITIONALLY, AT THE TIME OF THE CALL, DEXCOM TECHNICAL SUPPORT ADVISED PATIENT TO TEST THE "TRY IT" FEATURE FOR ALERT FUNCTIONALITY. THE PATIENT REPORTED, ONLY GOT VIBRATION WHEN TESTING HIGH AND LOW ALERT. NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490261 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649 5196137

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR