BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2980814 · Received February 27, 2013

    Report

    Report Number
    3004753838-2013-00048
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    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 SAME DAY DUE TO DISCOMFORT, THE SENSOR WIRE WAS MISSING FROM SENSOR POD. PATIENT REPORTED SENSOR DEPLOYMENT DIFFICULTY DURING INSERTION PROCESS, AND HE REMOVED THE SENSOR POD FROM HIS BODY WITHOUT THE TRANSMITTER ATTACHED, WHICH IS A PRACTICE AGAINST CGM'S USER'S GUIDE RECOMMENDATIONS. PATIENT REPORTED NO INDICATION OF THE WIRE AT INSERTION SITE. AT THE TIME OF HIS CALL TO TECHNICAL SUPPORT, PATIENT REPORTED SLIGHT REDNESS AT INSERTION SITE; NO INFLAMMATION OR PAIN. DEXCOM REQUESTED RETURN OF THE SENSOR FOR INVESTIGATION. PATIENT'S NURSE CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT PATIENT CAME IN FOR EVALUATION. NURSE REPORTS THAT NO SYMPTOMS OTHER THAN REDNESS WERE OBSERVED AT PATIENT'S INSERTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85070 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-03 5030002

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other