BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

    MDR report key: 5596400 · Received April 21, 2016

    Report

    Report Number
    3004753838-2016-11958
    Event Type
    Malfunction
    Date Received
    April 21, 2016
    Date of Event
    March 21, 2016
    Report Date
    March 29, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S HUSBAND CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES COMPARED TO BLOOD GLUCOSE (BG) METER THAT OCCURRED ON (B)(6) 2016. SENSOR WAS INSERTED ON (B)(6) 2016. IT WAS REPORTED THAT MULTIPLE BG METERS WERE USED THROUGHOUT THE SAME SENSOR SESSION. THE DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: USE THE SAME METER YOU ROUTINELY USE TO MEASURE YOUR BLOOD GLUCOSE TO CALIBRATE. DO NOT SWITCH YOUR METER IN THE MIDDLE OF A SENSOR SESSION. BLOOD GLUCOSE METER AND STRIP ACCURACY VARY BETWEEN BLOOD GLUCOSE METER BRANDS. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT DID NOT CALIBRATE AFTER EXPERIENCING INACCURACY. 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. AT THE TIME OF CONTACT, NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    A TRANSMITTER (PART NUMBER STT-GL-003/SERIAL NUMBER (B)(4)/LOT NUMBER 5203731) WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND FAILED TESTING. THE REPORTED EVENT OF INACCURACIES WAS NOT CONFIRMED BECAUSE INFORMATION ABOUT INACCURACIES CANNOT BE OBTAINED FROM THE TRANSMITTER. A ROOT CAUSE COULD NOT BE DETERMINED. IT IS UNKNOWN IF THE PRODUCT RETURNED IS THE PRODUCT AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250311 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR