BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1912717 · Received October 28, 2010

    Report

    Report Number
    3004753838-2010-00192
    Event Type
    Other
    Date Received
    October 28, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 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. THE EXACT AGE OF THIS PT IS NOT REASONABLY KNOWN TO DEXCOM. THE PT'S AGE HAS BEEN ESTIMATED TO BE >(B)(6) BASED ON NARRATIVE INFO CONTAINED IN THE PT'S COMPLAINT FILE. THE PT'S AGE IS REPORTED AS AN ESTIMATE PER THE INSTRUCTIONS FOR FORM FDA 3500A.

    Description of Event or Problem · 1

    PT CONTACTED DEXCOM SALES ON (B)(6) 2010 AND LEFT A VOICEMAIL TO REPORT THAT SHE EXPERIENCED PAIN AT THE INSERTION SITE SHORTLY AFTER INSERTING A SENSOR. UPON REMOVING THE SENSOR, PT FOUND THAT THE WIRE REMAINED UNDER HER SKIN SO SHE WENT TO HER DR TO HAVE IT REMOVED. PT'S STATUS AT THE TIME OF HER CALL TO DEXCOM SALES IS UNK. DEXCOM TECHNICAL SUPPORT MADE FOUR ATTEMPTS TO CONTACT THE PT FOR F/U BUT WAS UNABLE TO REACH HER.

    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 Other