BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2026825 · Received March 15, 2011

    Report

    Report Number
    3004753838-2011-00073
    Event Type
    Other
    Date Received
    March 15, 2011
    Date of Event
    October 1, 2010
    Report Date
    March 3, 2011
    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 CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT HE EXPERIENCED A TOTAL OF THREE BROKEN SENSOR WIRES. PATIENT REPORTED DIFFICULTY WITH INSERTION OF THE THIRD OF THESE THREE SENSORS, STATING THAT AN APPLICATOR PLUNGER WAS "GRABBY" AND DID NOT GO IN SMOOTHLY. AFTER EXAMINING THE SENSOR WIRE MORE CLOSELY, PATIENT NOTICED THAT HALF OF THE SENSOR WIRE WAS STILL INSIDE OF HIM, BRINGING HIS "INTERNAL WIRE COUNT UP TO THREE". WITH ALL THREE BROKEN SENSORS, PATIENT REPORTED THAT HE DID NOT SEE THE SENSOR WIRES PROTRUDING FROM HIS SKIN. IN ALL THREE CASES, THE WIRE EITHER SEEMED A LOT SHORTER THAN NORMAL OR WAS MISSING ENTIRELY. HE EXPERIENCED NO INFECTION OR INJURY, BUT REPORTED THAT THERE IS STILL AN UNHEALED SORE AT THE FIRST SENSOR INSERTION SITE. NO MEDICAL INTERVENTION WAS REQUIRED, AND PATIENT REPORTED THAT HE WAS FINE DURING A FOLLOW-UP CALL WITH DEXCOM TECHNICAL SUPPORT. THIS IS MDR 1 OF 3 FOR THE COMPLAINT. SEE MDRS #300475838-2011-00074 AND -0075 FOR REPORTS 2 AND 3.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other