BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1925498 · Received December 6, 2010

    Report

    Report Number
    3004753838-2010-00207
    Event Type
    Other
    Date Received
    December 6, 2010
    Date of Event
    October 24, 2010
    Report Date
    November 10, 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 HIS SENSOR PEELED OFF TWO DAYS AFTER INSERTION. UPON REMOVING THE SENSOR, HE NOTICED THAT THERE WAS NO SENSOR WIRE PRESENT. PT REPORTED THERE WAS A RED BUMP AT THE INSERTION SITE AND THAT THE INSERTION SITE WAS MORE IRRITATED THAN USUAL, SO HE ASSUMED THAT THE WIRE REMAINED UNDER HIS SKIN. PT ALSO REPORTED A LITTLE BIT OF DETECTABLE PAIN AT THE INSERTION SITE. NO MEDICAL INTERVENTION WAS REQUIRED. OTHER THAN EXPERIENCING IRRITATION AT THE INSERTION SITE, PT WAS FINE AT THE TIME OF HIS 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 5011661

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other