BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3171062 · Received June 14, 2013

    Report

    Report Number
    3004753838-2013-00160
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 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 ON DATE OF REPORT, UPON REMOVAL OF SENSOR DUE TO DEPLOYMENT ERROR, THE PATIENT COULD NOT SEE THE SENSOR WIRE ON THE UNDERSIDE OF THE SENSOR POD. NO PORTION OF THE WIRE WAS VISIBLE AT INSERTION SITE. DURING DEPLOYMENT, PATIENT REMOVED THE APPLICATOR PRIOR TO PULLING UP ON THE COLLAR, WHICH IS A PRACTICE AGAINST CGM'S USER'S GUIDE RECOMMENDATIONS. DURING A FOLLOW-UP CALL BETWEEN TECHNICAL SUPPORT AND THE PATIENT ON (B)(6) 2013, PATIENT REPORTED THAT SHE CONSULTED WITH HER ENDOCRINOLOGIST ON (B)(6) 2013. THE ENDOCRINOLOGIST ADVISED PATIENT TO MONITOR THE SENSOR INSERTION SITE FOR SIGNS OF IRRITATION. AT THE TIME OF HER INITIAL CALL TO TECHNICAL SUPPORT, PATIENT REPORTED SLIGHT NAUSEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271573 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5059640

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other