BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4897078 · Received July 7, 2015

    Report

    Report Number
    3004753838-2015-16637
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 10, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 FINGER STICK 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.

    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 ON (B)(6) 2015. THE SENSOR WAS INSERTED ON (B)(6) 2015. PATIENT DID NOT CALIBRATE ACCORDING TO USER GUIDE RECOMMENDATIONS. THE PATIENT DID NOT REPORT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438012 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5197065

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR