BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1912355 · Received November 22, 2010

    Report

    Report Number
    3004753838-2010-00203
    Event Type
    Other
    Date Received
    November 22, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 27, 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.

    Description of Event or Problem · 1

    PEDIATRIC PT IS A SUBJECT IN A CLINICAL TRIAL SPONSORED BY A PHARMACEUTICAL FIRM. ON (B)(6) 2010, STUDY INVESTIGATOR INFORMED DEXCOM THAT PT EXPERIENCED A BROKEN SENSOR WIRE ONE DAY AFTER INSERTION. PT HAD NO INJURIES, AND 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 5009813

    Patients

    Seq Age Sex Outcome Treatment
    1 Other