BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2061044 · Received April 4, 2011

    Report

    Report Number
    3004753838-2011-00082
    Event Type
    Other
    Date Received
    April 4, 2011
    Date of Event
    July 4, 2010
    Report Date
    July 5, 2010
    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 INTERVENTIONS.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2010 TO REPORT THAT HER DAUGHTER EXPERIENCED A FAILED SENSOR TWO DAYS AFTER INSERTION. UPON REMOVING THE SENSOR, SHE REALIZED THAT THE SENSOR WIRE APPEARED SHORTER THAN USUAL. PATIENT'S MOTHER WAS ABLE TO REMOVE THE WIRE WITH TWEEZERS. PATIENT EXPERIENCED ITCHING AND REDNESS AT THE INSERTION SITE, BUT NO MEDICAL INTERVENTION WAS REQUIRED, AND PATIENT WAS NORMAL AT THE TIME OF HER MOTHER'S CALL TO DEXCOM TECHNICAL SUPPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other