BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3061145 · Received April 16, 2013

    Report

    Report Number
    3004753838-2013-00097
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 18, 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 A FEW WEEKS PRIOR TO DATE OF REPORT DUE TO SENSOR FAILURE, THE SENSOR WIRE APPEARED SHORTER THAN NORMAL. THE PATIENT INITIALLY THOUGHT A PORTION OF THE WIRE MAY HAVE REMAINED BENEATH HER SKIN. AT THE TIME OF HER CALL, SHE STATED THAT NO PORTION OF THE WIRE REMAINED BENEATH HER SKIN. AT THE TIME OF A FOLLOW-UP CALL BY TECHNICAL SUPPORT TO THE PATIENT ON (B)(6) 2013, PATIENT REPORTED BEING IN FINE CONDITION. SHE REPORTED NO DISCOMFORT OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162352 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other