BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1912868 · Received November 9, 2010

    Report

    Report Number
    3004753838-2010-00196
    Event Type
    Other
    Date Received
    November 9, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 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 INTERVENTION.

    Description of Event or Problem · 1

    PT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2010 TO REPORT THAT HE EXPERIENCED A BROKEN SENSOR WIRE 6 DAYS AFTER INSERTION. PT REPORTED THAT HE HAD NOT SEEN THE WIRE SURFACE FROM UNDER HIS SKIN AND EXPERIENCED NO PAIN, INFLAMMATION, OR SWELLING. HE REPORTED NO INJURY, BUT INDICATED THAT THERE WAS A PINK DOT AT THE INSERTION SITE. NO MEDICAL INTERVENTION WAS REQUIRED.

    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 51 YR Other