BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3081523 · Received April 29, 2013

    Report

    Report Number
    3004753838-2013-00115
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEXCOM, INC. AND FDA AGREED DURING A FACILITY INSPECTION THAT ANY POSSIBLE BROKEN SENSOR WIRE WAS A REPORTABLE EVENT, EVEN IN THE ABSENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT UPON REMOVAL OF SENSOR ON DATE OF REPORT DUE TO DISCOMFORT, WIRE BECAME DETACHED FROM SENSOR POD AND REMAINED PROTRUDING FROM SKIN AT INSERTION SITE. PATIENT REMOVED THE SENSOR WIRE FROM HER SKIN. THE PATIENT REMOVED THE SENSOR POD FROM HER BODY WITHOUT THE TRANSMITTER ATTACHED, WHICH IS A PRACTICE AGAINST CGM'S USER'S GUIDE RECOMMENDATIONS. AT THE TIME OF HER CALL TO TECHNICAL SUPPORT, PATIENT REPORTED BEING IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183913 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5054707

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other