BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3822137 · Received May 20, 2014

    Report

    Report Number
    3004753838-2014-09276
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE DID NOT FIND ANY DEFECTS. REVIEW OF THE RECEIVER DATA LOG CONFIRMED THE REPORTED HARDWARE ERROR. THE ROOT CAUSE WAS DETERMINED TO BE RELATED FAILURES.

    Description of Event or Problem · 1

    PATIENT 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 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
    300355 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE: MDS MDS DEXCOM, INC. MT20649 5134480

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other