BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3924229 · Received July 9, 2014

    Report

    Report Number
    3004753838-2014-04935
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE DID NOT CONFIRM THE REPORTED INTERMITTENT AUDIO OUTPUT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400495 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other