BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3881514 · Received June 18, 2014

    Report

    Report Number
    3004753838-2014-09595
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 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 RESET THE DEVICE ON (B)(6) 2014. PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT. DEXCOM HAS ISSUED AN RGA FOR THE PATIENT TO RETURN THE DEVICE TO BE INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357081 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649 5117243

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other