BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5649406 · Received May 11, 2016

    Report

    Report Number
    3004753838-2016-12207
    Event Type
    Malfunction
    Date Received
    May 11, 2016
    Date of Event
    April 13, 2016
    Report Date
    April 13, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT SENSOR WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER (STT-GF-001 G5 /SERIAL NUMBER (B)(4)/LOT NUMBER 5210237) WAS RETURNED ON 06/10/2016. THE RETURNED TRANSMITTER 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.

    Description of Event or Problem · 1

    PATIENT'S MOTHER 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. THE SENSOR WAS INSERTED ON (B)(6) 2016. IT WAS REPORTED THAT AN ALTERNATIVE TESTING SITE (LEFT SIDE OF THE ABDOMEN) WAS USED TO TAKE BG READINGS. AT THE TIME OF CONTACT, NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. THE RECEIVER DATA LOG WAS PROVIDED BY THE PATIENT. THE DATA WAS REVIEWED ON 05/11/2016. THE REPORTED EVENT OF INACCURATE BLOOD GLUCOSE VALUES ON (B)(6) 2016 WAS CONFIRMED. IT WAS REPORTED THAT AN ALTERNATIVE TESTING SITE WAS USED (WRIST) TO CALIBRATE THE DEXCOM CGM SYSTEM. IT SHOULD BE NOTED THAT THE DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM STATES: USING A BLOOD SAMPLE FROM NON-FINGERTIP (ALTERNATE) SITES SUCH AS THE PALM, FOREARM OR UPPER ARM FOR METER READINGS. DO NOT USE ALTERNATIVE SITE TESTING TO CALIBRATE THE DEXCOM G5 MOBILE CGM SYSTEM, ONLY USE FINGERSTICK MEASUREMENT. ALTERNATIVE SITE BG VALUES FROM YOUR ARMS, PALM OF YOUR HAND, ETC., MAY BE DIFFERENT AND LESS ACCURATE THAN YOUR FINGERSTICK BG VALUES. USING ALTERNATIVE FOR CALIBRATION MIGHT AFFECT SENSOR PERFORMANCE, RESULTING IN YOU MISSING A SEVERE LOW OR HIGH GLUCOSE EVENT. HOWEVER, A ROOT CAUSE FOR THE REPORTED INACCURACY CANNOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303062 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5209493 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR