BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1912718 · Received October 28, 2010

    Report

    Report Number
    3004753838-2010-00189
    Event Type
    Other
    Date Received
    October 28, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 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 ABSCENCE 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 SHE EXPERIENCED A BROKEN SENSOR SHORTLY AFTER INSERTION. PT REPORTED THAT SHE NEVER GOT READINGS AND REMOVED THE SENSOR DUE TO BLOOD AND PAIN AT THE INSERTION SITE. UPON REMOVING THE SENSOR, SHE NOTICED THAT THE WIRE WAS STICKING OUT OF HER SKIN SO SHE REMOVED THE RETAINED FRAGMENT. PT REPORTED THAT, ASIDE FROM A BRUISE AT THE INSERTION SITE, THERE WERE NO INJURIES AND NO MEDICAL ATTENTION WAS REQUIRED. PT REPORTED SHE WAS FINE AT THE TIME OF HER 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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other