BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3171045 · Received June 14, 2013

    Report

    Report Number
    3004753838-2013-00159
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 20, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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) 2013 TO REPORT THAT ON (B)(6) 2013, UPON REMOVAL OF SENSOR DUE TO SENSOR FAILURE, PATIENT BECAME CONCERNED THAT A PORTION OF THE WIRE MAY HAVE REMAINED UNDER HIS SKIN. NO PORTION OF THE WIRE WAS VISIBLE AT INSERTION SITE. PATIENT STATED THAT HE COMPARED THE SENSOR IN QUESTION WITH A PREVIOUSLY USED SENSOR AND THEY APPEARED TO BE THE SAME LENGTH. PATIENT REQUIRED NO MEDICAL INTERVENTION. AT THE TIME OF HIS CALL TO TECHNICAL SUPPORT, PATIENT REPORTED SLIGHT BRUISING AND MILD PAIN AT INSERTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270754 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5046637

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other