BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MOINTORING SENSOR

    MDR report key: 2640598 · Received June 22, 2012

    Report

    Report Number
    3004753838-2012-00172
    Event Type
    Other
    Date Received
    June 22, 2012
    Date of Event
    May 16, 2012
    Report Date
    May 23, 2012
    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) 2012 TO REPORT THAT HER HUSBAND HAD HELPED HER PULL OUT, WITH TWEEZERS, A WIRE FROM HER ABDOMEN. PT BELIEVES THERE COULD BE A REMAINING FRAGMENT WILL LODGED IN HER SKIN. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PT STATES THAT SHE EXPERIENCES NO DISCOMFORT BUT STILL FEELS THE WIRE FRAGMENT IN HER SKIN FROM TIME TO TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MOINTORING SENSOR MDS DEXCOM, INC. 9500-03 5039770

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other