BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1925495 · Received December 6, 2010

    Report

    Report Number
    3004753838-2010-00208
    Event Type
    Other
    Date Received
    December 6, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 15, 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 SHE EXPERIENCED A FAILED SENSOR FIVE DAYS AFTER INSERTION. PT REPORTED THAT SHE GOT ERRATIC READINGS THE DAY HER SENSOR FAILED, WITH CGM READINGS AT 312 MG/DL WHEN HER BLOOD GLUCOSE READING WAS AT 132 MG/DL. PT REMOVED THE SENSOR INSTEAD OF RE-CALIBRATING. UPON REMOVING THE SENSOR, SHE NOTICED THAT LENGTH OF THE SENSOR WIRE WAS "NOT QUITE RIGHT." SHE REPORTED THAT A SMALL SLIVER OF THE WIRE WAS STICKING OUT OF HER SKIN SO SHE REMOVE IT WITH TWEEZERS. PT REPORTED NO INJURIES AND NO DISCOMFORT OR IRRITATION AT THE INSERTION SITE. NO MEDICAL INTERVENTION WAS REQUIRED, AND PT 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 5008220

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other