BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1994417 · Received February 1, 2011

    Report

    Report Number
    3004753838-2011-00024
    Event Type
    Other
    Date Received
    February 1, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 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 FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT PATIENT EXPERIENCED A FAILED SENSOR ONE DAY AFTER INSERTION. UPON REMOVING THE SENSOR, PATIENT'S FATHER NOTICED THE SENSOR WIRE WAS BROKEN. PATIENT'S FATHER REPORTED THAT THERE WERE SMALL RED BUMPS AT THE INSERTION SITE BUT INDICATED THAT THEY DID NOT LOOK CONCERNING. HE CONFIRMED THAT HE COULD NOT SEE THE RETAINED WIRE UNDER PATIENT'S SKIN. NO MEDICAL INTERVENTION WAS REQUIRED, AND PATIENT'S FATHER REPORTED THAT PATIENT DID NOT EXPERIENCE ANY PAIN AT THE INSERTION SITE. PATIENT WAS FINE AT THE TIME OF HIS FATHER'S CALL TO DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5009898

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other