BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING

    MDR report key: 2930187 · Received January 25, 2013

    Report

    Report Number
    3004753838-2013-00032
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Report Date
    January 6, 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 DATE OF REPORT DUE TO SENSOR ERROR, THE WIRE ON THE UNDERSIDE OF THE SENSOR POD APPEARED SHORTER THAN NORMAL. THERE WAS NO INDICATION OF ANY PORTION OF THE WIRE AT THE SENSOR INSERTION SITE, BUT THE PATIENT BELIEVES A PORTION OF THE WIRE REMAINED UNDER HIS SKIN. DEXCOM REQUESTED A DATA DOWNLOAD AND THE SENSOR TO BE RETURNED FOR INVESTIGATION. THE PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT PATIENT SOUGHT MEDICAL INTERVENTION ON (B)(6) 2013. AN X-RAY WAS PERFORMED AND APPEARED TO SHOW 3 FRAGMENTS OF WIRE IN THE SUBCUTANEOUS TISSUE OF THE PATIENT'S BUTTOCKS. THE PATIENT REPORTED THAT BECAUSE OF THE DISTANCE BETWEEN THE FRAGMENTS, HE BELIEVES THAT TWO OF THE FRAGMENTS WERE FROM SENSORS INSERTED ON PREVIOUS DATES. INFORMATION ABOUT THESE SENSORS AND THE POSSIBLE INCIDENTS WAS UNAVAILABLE. AT THE TIME OF THE FOLLOW-UP CALL TO TECHNICAL SUPPORT, PATIENT WAS REPORTED TO BE WORRIED. THE PATIENT'S INSERTION SITE WAS REPORTED TO BE RED AND SLIGHTLY INFLAMED, WITH NO BLEEDING, DRAINAGE, SWELLING, OR PAIN. THIS IS MDR 2 OF 3 FOR THE COMPLAINT. SEE MDR# 3004753838-2013-00031 AND 3004753838-2013-00033 FOR REPORTS 1 AND 3 OF 3, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35581 SEVEN CONTINUOUS GLUCOSE MONITORING MDS MDS DEXCOM, INC. 9500-03

    Patients

    Seq Age Sex Outcome Treatment
    1 Other