BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3895331 · Received June 25, 2014

    Report

    Report Number
    3004753838-2014-23038
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(4) 2014 TO REPORT AN OUT OF RANGE SIGNAL ON (B)(4) 2014. DEXCOM TECHNICAL SUPPORT ADVISED THE PATIENT TO RESET THE DEVICE ON (B)(4) 2014. DEXCOM HAS ISSUED A RGA FOR PATIENT TO RETURN THE DEVICE TO BE INVESTIGATED. PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372093 G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT22430 5150416

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other