BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3821785 · Received May 20, 2014

    Report

    Report Number
    3004753838-2014-22195
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 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). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DAMAGE WAS FOUND. FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS RECEIVED IN A CONDITION MAKING EVALUATION NOT POSSIBLE. THEREFORE THE COMPLAINT OF INTERMITTENT OUT OF RANGE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT AN OUT OF RANGE SIGNAL ON (B)(6) 2014. PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299051 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE:MDS MDS DEXCOM INC. 9438-01 5135387

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other