BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1657815 · Received April 6, 2010

    Report

    Report Number
    3004753838-2010-00082
    Event Type
    Other
    Date Received
    April 6, 2010
    Date of Event
    March 24, 2010
    Report Date
    March 29, 2010
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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. PT'S MOTHER WAS ADVISED, PER SCRIPT, THAT IN THE RARE INSTANCES WHEN A BROKEN SENSOR HAS OCCURRED IN THE PAST, CONSULTING PHYSICIANS AND SURGEONS HAVE RECOMMENDED NOT TO REMOVE THE WIRE FRAGMENT AS LONG AS THERE ARE NOT SIGNS OR SYMPTOMS OF INFECTION OR INFLAMMATION. IN THE EVENT THAT SIGNS OR SYMPTOMS OF INFECTION OR INFLAMMATION ARISE, SUCH AS REDNESS, SWELLING, OR PAIN, PT'S MOTHER WAS ADVISED TO CONSULT THE PRESCRIBING PHYSICIAN. PT'S MOTHER WAS FURTHER ADVISED THAT IF THERE WAS NO PORTION OF THE BROKEN WIRE FRAGMENT VISIBLE ABOVE THE SKIN, ATTEMPTS TO REMOVE THE WIRE FRAGMENT WITHOUT MEDICAL GUIDANCE WERE NOT ADVISED.

    Description of Event or Problem · 1

    A PHYSICIAN AT A CHILDREN'S HOSPITAL SENT AN E-MAIL REPORTING THAT A PEDIATRIC PT OF HIS HAD BORROWED A DEXCOM SYSTEM AND EXPERIENCED A POSSIBLE BROKEN SENSOR WIRE. THE PT'S MOTHER WAS CONTACTED BY DEXCOM TECHNICAL SUPPORT ON (B)(6), 2010, PT'S MOTHER STATED THAT HER SON IS NOT DIABETIC, BUT EXPERIENCES SEVERE SUGAR FLUCTUATIONS. PT'S MOTHER REPORTED THAT HER SON WAS AGITATED ON THE THIRD NIGHT OF SENSOR WEAR AND WAS SCRATCHING AT THE INSERTION SITE. PT PULLED THE SENSOR OFF COMPLETELY AND HIS MOTHER NOTICED THAT THE PROXIMAL END OF THE SENSOR WIRE AS MUCH SHORTER THAN NORMAL. PT'S MOTHER BELIEVES THE DISTAL END WAS RETAINED UNDER PT'S SKIN. PT'S MOTHER STATED THAT THE INSERTION SITE HAD A DIME-SIZE SCAB AND WAS HOT AND SWOLLEN. THE SITE REMAINED HOT AND HAD SPASMS, CAUSING THE PT "GREAT DISCOMFORT". THE INSERTION SITE HAD RETURNED TO NORMAL AFTER 3-4 DAYS, PRIOR TO THE TIME DEXCOM TECHNICAL SUPPORT MADE CONTACT WITH PT'S MOTHER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other