BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3945475 · Received July 21, 2014

    Report

    Report Number
    3004753838-2014-05813
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014 UPON SENSOR APPLICATOR REMOVAL, SENSOR WIRE DETACHED FROM THE SENSOR POD. MOTHER REPORTED APPLYING PRESSURE AND APPLYING NEOSPORIN TO THE WOUND SITE. PATIENT DID NOT REPORT ANY FURTHER INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424944 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5150494

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other