BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2862895 · Received December 10, 2012

    Report

    Report Number
    3004753838-2012-00332
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    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) 2012, TO REPORT THAT UPON REMOVAL OF SENSOR ON SAME DAY DUE TO SENSOR DEPLOYMENT DIFFICULTY, THE SENSOR WIRE WAS MISSING FROM SENSOR POD. PATIENT REPORTED BEING ABLE TO SEE THE SENSOR WIRE PROTRUDING FROM HIS SKIN AT THE INSERTION SITE. HE REMOVED THE WIRE FROM HIS SKIN. AT THE TIME OF HIS CALL TO TECHNICAL SUPPORT, PATIENT REPORTS THAT NO MEDICAL INTERVENTION WAS REQUIRED AND THAT HE IS IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-03 5040475

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other