BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM

    MDR report key: 4903491 · Received July 9, 2015

    Report

    Report Number
    3004753838-2015-23080
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 15, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION AND DATA WAS NOT PROVIDED; THEREFORE, THE REPORTED COMPLAINT OF HARDWARE ERROR CANNOT BE CONFIRMED. IT WAS 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 HARDWARE ERROR CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    PATIENT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 AND CLAIMED THAT ON (B)(6) 2015 THE PATIENT EXPERIENCED A HARDWARE FAILURE. 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
    447004 DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22495-PNK 5198510

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR