BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3874302 · Received June 16, 2014

    Report

    Report Number
    3004753838-2014-08722
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 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 COMPLAINT SENSOR DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, DATA WAS RECEIVED AND DOWNLOADED ON 02/03/2015. A REVIEW OF THE DOWNLOADED DATA LOG CONFIRMED THE REPORTED EVENT OF INACCURATE BLOOD GLUCOSE VALUES.

    Description of Event or Problem · 1

    PATIENT'S PARENTS CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT CGM INACCURACY COMPARED TO BLOOD GLUCOSE METER ON (B)(6) 2014. PATIENT'S PARENTS 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
    352367 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5135345

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other