BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2582831 · Received May 16, 2012

    Report

    Report Number
    3004753838-2012-00134
    Event Type
    Other
    Date Received
    May 16, 2012
    Date of Event
    April 22, 2012
    Report Date
    April 23, 2012
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT UPON SENSOR REMOVAL DUE TO EARLY SENSOR SHUTOFF, HE NOTICED THAT SENSOR WIRE WAS MISSING. DURING THE CALL TO DEXCOM TECHNICAL SUPPORT IT APPEARED THAT PATIENT'S FATHER WASN'T USING PROPER INSERTION TECHNIQUE WHICH COULD HAVE CAUSED THE SENSOR WIRE TO RETRACT INTO ITS APPLICATOR AND NEVER INSERT IN PATIENT'S SKIN. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT'S FATHER REPORTED THAT THERE WAS SOME LINGERING SENSITIVITY ON THE INSERTION SITE BUT THAT PATIENT HAD NOT SOUGHT MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5038072

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other