BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4923325 · Received July 17, 2015

    Report

    Report Number
    3004753838-2015-17172
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 24, 2015
    Report Date
    June 24, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION AND DATA WAS NOT PROVIDED; THEREFORE, THE REPORTED COMPLAINT OF INACCURACIES CANNOT BE CONFIRMED. IT WAS REPORTED THAT THE PATIENT DID NOT ENTER FINGERSTICK VALUES PROMPTLY AND ACCURATELY. IT SHOULD BE NOTED THAT THE DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: TO CALIBRATE THE SYSTEM, ENTER THE EXACT BLOOD GLUCOSE VALUE THAT YOUR BLOOD GLUCOSE METER DISPLAYS WITHIN 5 MINUTES OF A CAREFULLY PERFORMED BLOOD GLUCOSE MEASUREMENT. ENTERING INCORRECT BLOOD GLUCOSE VALUES OR BLOOD GLUCOSE VALUES FROM MORE THAN 5 MINUTES BEFORE ENTRY MIGHT AFFECT SENSOR PERFORMANCE, AND YOU MIGHT MISS A LOW OR HIGH BLOOD GLUCOSE VALUE. IT WAS REPORTED THAT THE PATIENT DID NOT CALIBRATE AFTER EXPERIENCING INACCURACY. IT SHOULD BE NOTED THAT THE DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: IF THE DIFFERENCE BETWEEN YOUR SENSOR GLUCOSE READING AND BLOOD GLUCOSE VALUE IS GREATER THAN 20% OF THE BLOOD GLUCOSE VALUE FOR SENSOR GLUCOSE READINGS > 80 MG/DL OR GREATER THAN 20 POINTS FOR SENSOR GLUCOSE READINGS < 80 MG/DL, WASH YOUR HANDS AND TAKE ANOTHER BLOOD GLUCOSE MEASUREMENT. IF THE DIFFERENCE BETWEEN THIS SECOND BLOOD GLUCOSE MEASUREMENT AND THE SENSOR IS STILL GREATER THAN 20% FOR SENSOR GLUCOSE READINGS > 80 MG/DL OR GREATER THAN 20 POINTS FOR SENSOR GLUCOSE READINGS < 80 MG/DL, RECALIBRATE YOUR SENSOR USING THE SECOND BLOOD GLUCOSE VALUE. THE SENSOR GLUCOSE READING WILL CORRECT OVER THE NEXT 15 MINUTES.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED ON (B)(6) 2015, AND THE INACCURACY WAS NOTICED ON (B)(6) 2015. PATIENT DID NOT CALIBRATE PROPERLY ACCORDING TO USER GUIDE RECOMMENDATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464893 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5198757

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR