BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3844215 · Received June 2, 2014

    Report

    Report Number
    3004753838-2014-09377
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 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

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED COMPLAINT DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. EVALUATION OF THE RETURNED RECEIVER CONFIRMED A HARDWARE ERROR CODE. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE COMPONENT IN THE RECEIVER'S PRINTED CIRCUIT BOARD.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014 PATIENT EXPERIENCED A HARDWARE FAILURE. DEXCOM TECHNICAL SUPPORT ADVISED PATIENT'S MOTHER TO RESTART DEVICE ON (B)(6) 2014. DEXCOM HAS ISSUED AN RGA FOR PATIENT TO RETURN THEIR DEVICE TO BE INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321882 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE: MDS MDS DEXCOM, INC. MT20649 5053559

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other