BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM

    MDR report key: 4842303 · Received June 12, 2015

    Report

    Report Number
    3004753838-2015-22670
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 19, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. A REVIEW OF THE DOWNLOADED RECEIVER LOG CONFIRMED THE REPORTED EVENT OF A FIRMWARE ERROR. A ROOT CAUSE COULD NOT BE DETERMINED.THE DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM REV. 11, UNDER SECTION 13.8.2 RECEIVER ERROR CODE NOTES THE FOLLOWING: THIS SCREEN SHOWS AN ERROR CODE THAT MEANS THE RECEIVER MAY NOT BE WORKING PROPERLY. WRITE DOWN THE ERROR CODE AND CONTACT DEXCOM TECHNICAL SUPPORT. CONTINUE TO CHECK YOUR BLOOD GLUCOSE VALUE USING YOUR BLOOD GLUCOSE METER. NO ALERT SOUND OR VIBRATION WILL WARN YOU THAT YOU ARE NO LONGER GETTING SENSOR GLUCOSE READINGS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE. IT IS ALSO REPORTED THAT A PEDIATRIC PATIENT WAS USING A RECEIVER APPROVED ONLY FOR ADULTS. IT SHOULD BE NOTED THAT THE DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM STATES: THE DEXCOM G4 SYSTEM IS NOT APPROVED FOR USE IN CHILDREN OR ADOLESCENTS, PREGNANT WOMEN OR PERSONS ON DIALYSIS. HOWEVER, A ROOT CAUSE FOR THE REPORTED FIRMWARE ERROR CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    PATIENT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT THAT THE RECEIVER DISPLAYED A FIRMWARE ERROR ON (B)(6) 2015. PEDIATRIC PATIENT WAS USING ADULT RECEIVER. THE PATIENT'S FATHER DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385754 DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22495-PNK 5197984

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR