BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2582809 · Received May 16, 2012

    Report

    Report Number
    3004753838-2012-00135
    Event Type
    Other
    Date Received
    May 16, 2012
    Date of Event
    April 21, 2012
    Report Date
    April 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

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT UPON SENSOR REMOVAL DUE TO SENSOR ERROR, SHE NOTICED THAT SENSOR WIRE WAS SHORTER THAN USUAL. PATIENT'S MOTHER IS CONCERNED THAT A SENSOR FRAGMENT IS INSIDE PATIENT'S SKIN. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT'S MOTHER REPORTED THAT PATIENT WAS DOING FINE AND THAT THE INSERTION SITE LOOKED GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5038114

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other