BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1912357 · Received November 22, 2010

    Report

    Report Number
    3004753838-2010-00206
    Event Type
    Other
    Date Received
    November 22, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 3, 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 HER SENSOR FELL OFF TWO DAYS AFTER INSERTION. SHE REPORTED THAT THE SENSOR WIRE WAS NOT PRESENT AFTER THE SENSOR FELL OFF. SHE BELIEVED THAT THE WIRE WAS STILL UNDER HER SKIN BUT REPORTED NO INJURY AND HAD NO SIGNS OF INFECTION AT THE INSERTION SITE. NO MEDICAL ATTENTION 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 5009879

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other