BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3895408 · Received June 25, 2014

    Report

    Report Number
    3004753838-2014-04840
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 1, 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

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT DEVICE WAS RETURNED TO DEXCOM AND EVALUATED. THE REPORTED FAILURE WAS NOT CONFIRMED AND NO DEFECT WAS FOUND.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED NO AUDIO OUTPUT (B)(6) 2014. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED. ADDITIONALLY, PATIENT'S MOTHER TESTED ALERT FUNCTIONALITY AND PATIENT'S MOTHER REPORTED ALERTS WERE FUNCTIONAL. DEXCOM HAS ISSUED AN RGA FOR PATIENT TO RETURN THE DEVICE TO BE INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369987 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE:MDS MDS DEXCOM INC. MT22430-BLU 5150439

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other