BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1994416 · Received February 1, 2011

    Report

    Report Number
    3004753838-2011-00018
    Event Type
    Other
    Date Received
    February 1, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 12, 2011
    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 MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT HER DAUGHTER EXPERIENCED A TOTAL OF FIVE POSSIBLE SENSOR WIRE BREAKS. PATIENT'S MOTHER REPORTED THAT, UPON REMOVING A SENSOR THE LAST WEEK IN (B)(6), A WIRE FRAGMENT WAS LEFT UNDERNEATH PATIENT'S SKIN, IN HER UPPER ARM. PATIENT WAS X-RAYED PER REFERRAL FROM HER PEDIATRIC ENDOCRINOLOGIST. X-RAYS ON BOTH UPPER ARMS REVEALED A TOTAL OF FIVE POSSIBLE RETAINED SENSOR WIRE FRAGMENTS. PATIENT'S MOTHER WAS UNSURE WHEN THE SENSOR WIRE BREAKS OCCURRED AND INDICATED THAT PATIENT DID NOT SEEM TO BE BOTHERED BY THE RETAINED FRAGMENTS. THIS IS MDR 5 OF 5 FOR THE COMPLAINT. REFER TO THE FOLLOWING MDRS FOR COMPLETE REPORTING OF THIS COMPLAINT: 3004753838-2011-00014 (1 OF 5), 3004753838-2011-00015 (2 OF 5), 3004753838-2011-00016 (3 OF 5), 3004753838-2011-00017 (4 OF 5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5011668

    Patients

    Seq Age Sex Outcome Treatment
    1 36 MO Other