BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3854755 · Received June 6, 2014

    Report

    Report Number
    3004753838-2014-05656
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 12, 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)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014, UPON SENSOR APPLICATOR REMOVAL, SENSOR WIRE BECAME DETACHED FROM SENSOR POD. PATIENT'S MOTHER STATED THAT THE SENSOR WIRE FELL INTO THE PATIENT'S LAP. AT THE TIME OF THE CALL WITH DEXCOM TECHNICAL SUPPORT, PATIENT'S MOTHER REPORTED NO INJURIES OR MEDICAL INTERVENTION. 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
    331312 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE: MDS MDS DEXCOM, INC. 9500-27 5145445

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other